Suturing devices and methods for suturing an anatomic valve

ABSTRACT

Suturing apparatuses configured to suture biological tissue, such as an anatomical valve, can include an elongate member having a proximal end, a distal end, one or more arms, and one or more needles. A protective member may be used to inhibit contact between a distal end of a needle and surrounding tissue. Methods for suturing bodily tissue such as an anatomical valve may be performed with the suturing apparatuses. The suturing apparatuses may be used to suture adjacent valve leaflets or the base of a valve in order to treat or repair the valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication, are hereby incorporated by reference under 37 CFR 1.57.This application is a U.S. National Phase of International ApplicationNo. PCT/US2012/033396, filed Apr. 12, 2012, which claims the benefit ofU.S. Provisional Application No. 61/476,236, filed Apr. 15, 2011, theentirety of both of which are hereby incorporated by reference.

TECHNICAL FIELD

Embodiments of the present inventions relate to suturing devices andmethods. Some embodiments of the present invention relate to suturingdevices and methods for suturing an anatomic valve, for example, a heartvalve such as a mitral valve, an aortic valve, a tricuspid valve, or apulmonary valve.

BACKGROUND

Health practitioners frequently use sutures to close various openingssuch as cuts, punctures, and incisions in various places in the humanbody. Generally, sutures are convenient to use and function properly tohold openings in biological tissue closed thereby aiding in bloodclotting, healing, and prevention of scaring.

There are some circumstances under which it is not feasible to useconventional sutures and suturing methods to close an opening.Additionally, there are some circumstances under which the use ofconventional sutures and suturing methods require invasive proceduresthat subject a patient to risk of infection, delays in recovery,increases in pain, and other complications.

Some heart valves may be weakened or stretched, or may have otherstructural defects, such as congenital defects, that cause them to closeimproperly, which can lead to blood flow contrary to the normal flowdirection. This condition, referred to as regurgitation, incompetence,or insufficiency, can reduce blood flow in the normal direction.Regurgitation causes the heart to work harder to compensate for backflowof blood through these valves, which can lead to enlargement of theheart that reduces cardiac performance. While the tricuspid valve andthe pulmonary valve may present these conditions, the mitral valve andaortic valve more frequently demonstrate these conditions.

A number of procedures have been developed to repair valves that do notclose properly. Among these procedures is the Alfieri technique,sometimes called edge-to-edge repair, which involves suturing edges ofthe leaflets and pulling the leaflets closer together. In anothertechnique, the chordae tendineae are replaced or shortened. A patch issometimes applied to leaflets that have openings therein. In someinstances, leaflets are reshaped by removing a section of the leafletthat is to be treated and the surrounding portion of the leaflet issutured closed. Some valves are treated by attaching a ring around theoutside of the malfunctioning valve. In a mitral valve annuloplasty, forexample, a device such as in the shape of a ring or a partial ring maybe implanted surrounding the mitral valve to pull the leaflets together.Sutures may be used to attach the annuloplasty ring to the base of thevalve. Other valves may be replaced with biological or mechanicalreplacements. These procedures are frequently performed by highlyinvasive procedures, which sometimes require opening a patient's chest,stopping the patient's heart and routing blood through a heart-lungmachine. Robotically-assisted procedures have been employed to reducethe size of the openings required for such procedures.

SUMMARY OF THE DISCLOSURE

Embodiments of suturing devices and methods for suturing biologicaltissue are disclosed herein. The suturing devices and their methods ofuse can be useful in a variety of procedures, such as treating (e.g.,closing) wounds and naturally or surgically created apertures orpassageways. For example, the suturing devices can be used to treat ananatomical valve, such as a heart valve, including heart valves that maybe weakened or stretched, or have other structural defects, such ascongenital defects, that cause them to close improperly. In someembodiments, one or more suturing devices can be used to treat or repairvalves, such as the tricuspid, pulmonary, mitral, and aortic valves, forexample. In some embodiments, one or more suturing devices can be usedto perform procedures such as edge-to-edge repair (like an Alfieritechnique), annuloplasty (with or without a ring or other implant),suturing of ventricular spaces, suturing of the chordae, suturing inother locations in the heart, replacement of the chordae tendineae,shortening of the chordae tendineae, patch application, leafletreshaping, and attachment of prosthetics, such as rings and biologicalor mechanical replacement valves, for example.

In some embodiments, the suturing devices can be used to close or reducea variety of other tissue openings, lumens, hollow organs or natural orsurgically created passageways in the body. In some embodiments, thesuturing devices can be used to suture prosthetics, synthetic materials,or implantable devices in the body. For example, the devices can be usedto suture pledget within the body.

In some embodiments, a suturing device can comprise an elongate bodyhaving a distal end, a single arm, a needle, and a protective member.The single arm can be connected with the elongate body near the distalend for movement between a retracted position and an extended position.The arm can comprise a first suture mount located near a free end of thearm and configured to releasably retain a first suture portion. A needlecan be configured to move between a retracted position and a deployedposition to retrieve the first suture potion retained in the firstsuture mount when the first needle is moved from the retracted positionto the advanced position and returned to the retracted position. Thefirst protective member can be configured to inhibit contact between adistal end of the first needle and surrounding tissue during at least aportion of the movement of the first needle from its retracted positiontoward its deployed position.

In some embodiments, a suturing device can comprise an elongate bodyhaving a proximal end and a distal end, and a handle at the proximalend. A first arm and a second arm can connect to the elongate body nearthe distal end, and the first arm and the second arm can be configuredto move between a first position, in which the first arm and second armare retracted within the elongate body, and a second position, in whichthe first arm and the second arm have free ends extending away from theelongate body. The first arm and the second arm can form an anglebetween each other and can each have at least one suture mount at theirfree ends. The suture mounts can be configured to releasably retain asuture portion. A needle arm can connect to the elongate body proximalto the first and second arm, and can extend from a retracted position,in which the needle arm is retracted in the elongate body, to anextended position, in which the needle arm extends distally andoutwardly from the elongate body. The needle arm can rotate around theelongate body at least between a first position where the needle arm isaligned with the free end of the first arm and a second position wherethe needle arm is aligned with the free end of the second arm. Thedevice can also comprise a first needle and a second needle that canhave a retracted position in which a distal point of each needle iswithin the needle arm. The first needle can move from the retractedposition to a deployed position in which the distal point of the firstneedle extends out of the needle arm into the suture mount of the firstarm when the needle arm is in the first position. The second needle canmove from the retracted position to a deployed position in which thedistal point of the second needle extends out of the needle arm into thesuture mount of the second arm when the needle arm is in the secondposition.

Methods of suturing anatomic valves are also described. In someembodiments, an elongate body can be positioned at least partiallywithin the anatomic valve. An arm can be deployed from the elongate bodywith the first arm releasably holding a first suture portion. A free endof the arm can be positioned at or near a base of the valve. A firstneedle can be deployed from the elongate body such that the first needlepenetrates the valve at a first location and engages the first sutureportion. The valve tissue and surrounding anatomy can be protected froma distal end of the first needle as the first needle is deployed to thefirst location. The first suture portion can be drawing through theleaflet. A second suture portion can be passed through the valve at asecond location. The first and second suture portions can be securedtogether.

In some embodiments, an anatomic valve can be sutured by positioning anelongate body at least partially within the anatomic valve, deploying anarm from the elongate body on a first side of a valve with the first armreleasably holding first and second suture portions. A free end of thearm can be positioned at or near a base of the valve. First and secondneedles can be deployed from the elongate body on a second side of thevalve such that the first needle penetrates the valve at a firstlocation and engages the first suture portion and the second needlepenetrates the valve at a second location and engage the second sutureportion. The first and second suture portions can be drawn through thevalve from the first side to the second side. The first and secondsuture portions can be secured together.

In some embodiments, an anatomic valve can be sutured by positioning anelongate body at least partially within the anatomic valve and deployingat least two arms from the elongate body with each arm releasablyholding a suture portion. A free end of each of the arms can bepositioned at or near a base of the valve. Needles can be deployed fromthe elongate body such that each needle penetrates the valve and engagesa corresponding suture portion. The suture portions can be drawn throughthe leaflet. The suture portions can be secured together in groups of noless than two.

In some embodiments, an anatomic valve can be sutured by positioning asuturing device comprising an elongate body through the valve andextending a plurality of arms from the elongate body of the suturingdevice, with each of the arms carrying an end of a suture. At least apair of arms can be positioned at or near a base of the valve. Aprotection member can be extended from the elongate body toward a firstone of the arms positioned at or near a base of the valve. A needle canbe advanced through the protection member, through tissue of the valveat a first location, and into contact with a first one of the sutureends carried by the first arm. The needle can be retracted through thetissue of the valve to draw the first suture end through the tissue. Theprotection member can be rotated along the elongate body such that theprotection member extends toward a second one of the arms positioned ator near a base of the valve. A needle can be advanced through theprotection member, through tissue of the valve at a second location, andinto contact with a second one of the suture ends carried by the secondarm. The needle can be retracted through the tissue of the valve to drawthe second suture end through the tissue. A distance between the firstand second locations can be closed with said suture placed through saidlocations.

In some embodiments, a mitral valve can be sutured by delivering asuturing device transapically through the heart and into the leftventricle. The suturing device can have a proximal end, a distal end, anelongate body extending between the proximal end and the distal end, anda handle at the proximal end. At least the distal end of the device canbe delivered through the mitral valve. A first arm and a second arm canbe extended from the elongate body from a first position, in which thefirst arm and the second arm are retracted into the elongate body, to asecond position, in which the first arm and the second arm have freeends extending away from the elongate body. The first arm can carry afirst suture end and the second arm can carry a second suture end. Thefirst and second arm can be at or near a base of the valve on the atrialside of the valve.

A needle arm can be extended from a retracted position in which theneedle arm is retracted into the elongate body to an initial extendedposition in which the needle arm is located proximal to the arms. Theneedle arm in the initial extended position can extend outwardly awayfrom the elongate body in a distal direction on the ventricular side ofthe valve between adjacent chordae. The needle arm can be rotated towardthe first arm with the needle arm remaining on the ventricular side ofthe valve such that the needle arm extends toward the first armpositioned at or near a base of the valve.

A first needle can be advanced distally out of the needle arm, throughtissue of the valve at a first location, and into contact with the firstsuture end. The first needle can be retracted through the tissue of thevalve to draw the first suture end through the tissue, and a firstlength of suture can run from the first suture end through the tissue.The needle arm can be rotated toward the second arm with the needle armremaining on the ventricular side of the valve such that the needle armextends toward the second arm positioned at or near a base of the valve.A second needle can be advanced distally out of the needle arm, throughtissue of the valve at a second location, and into contact with thesecond suture end. The second needle can be retracted through the tissueof the valve to draw the second suture end through the tissue, and asecond length of suture can run from the second suture end through thetissue.

The needle arm can be rotated back to the initial extended position. Theneedle arm can be moved proximally back to the retracted position. Thefirst and second arms can be moved from the second position back to thefirst position. The suturing device can be withdrawn from the mitralvalve, and the first and second lengths of suture can remain within thetissue. A first distance between the first and second locations can beclosed to a second distance between the first and second locations.

In some embodiments, tissue can be sutured by delivering a suturingdevice to a location adjacent the tissue. The suturing device can have aproximal end, a distal end, an elongate body extending between theproximal end and the distal end, and a handle at the proximal end. Atleast the distal end of the device can be delivered to the locationadjacent the tissue. A first arm and a second arm can be extended fromthe elongate body from a first position, in which the first arm and thesecond arm are retracted into the elongate body, to a second position,in which the first arm and the second arm have free ends extending awayfrom the elongate body and the first arm and second arm form an anglebetween each other. The first arm can carry a first suture end and thesecond arm can carry a second suture end. The first and second arm canbe adjacent a first side of the tissue.

A needle arm can be moved from a retracted position in which the needlearm is retracted into the elongate body to an extended position in whichthe needle arm extends toward the first arm. The needle arm can belocated on the opposite side of the tissue from the first arm and thesecond arm. A first needle can be advanced out of the needle arm,through tissue at a first location, and into contact with the firstsuture end. The first needle can be retracted through the tissue to drawthe first suture end through the tissue, and a first length of suturecan run from the first suture end and through the tissue. The needle armcan be rotated toward the second arm such that the needle arm extendstoward the second arm. A second needle can be advanced out of the needlearm, through tissue at a second location, and into contact with thesecond suture end. The second needle can be retracted through the tissueto draw the second suture end through the tissue, and a second length ofsuture can run from the second suture end and through the tissue.

The needle arm can be moved back to the retracted position. The firstand second arms can be moved from the second position back to the firstposition. The suturing device can be withdrawn from the tissue location,and the first and second lengths of suture can remain within the tissue.

In some embodiments, an anatomic valve can be sutured by positioning anelongate body at least partially within the anatomic valve. A first armcan be deployed from the elongate body, and the first arm can releasablyhold a first suture portion at a free end. The free end of the first armcan be positioned at or near an edge of a first leaflet on a first sideof the valve. A first needle arm can be deployed from the elongate bodyon an opposite side of the valve such that the first leaflet ispositioned between the needle arm and the first arm. A first needle canbe deployed from the first needle arm such that the first needlepenetrates the first leaflet at a first location and engages the firstsuture portion. The first suture portion can be drawn through the firstleaflet. A second suture portion can be passed through the secondleaflet at a second location, and the two leaflets can be drawn togetherusing a suture placed through the first and second location.

The disclosure describes examples of some embodiments of the inventions.The designs, figures, and description are non-limiting examples of someembodiments of the inventions. Other embodiments of the devices andmethods may or may not include the features disclosed herein. Moreover,disclosed advantages and benefits may apply to only some embodiments ofthe inventions, and should not be used to limit the inventions.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features disclosed herein are describedbelow with reference to the drawings of specific embodiments. Theillustrated embodiments are intended for illustration, but notlimitation. The drawings contain the following figures:

FIG. 1 illustrates a method of providing access to an exemplifying useenvironment, such as an aortic valve of a heart.

FIG. 2A illustrates a method of providing access to an exemplifying useenvironment, such as a mitral valve of a heart.

FIG. 2B illustrates a method of providing access to an exemplifying useenvironment, such as a mitral valve of a heart.

FIG. 3 is a perspective view of an embodiment of a suturing device withsuture clasp arms in a retracted position and a casing shown incross-section.

FIG. 4 is an enlarged perspective view of the embodiment of FIG. 3 withthe casing shown in cross-section, showing suture catch mechanisms in apartially advanced position.

FIG. 5 is a perspective view of the embodiment of FIG. 3, with thesuture clasp arms in an extended position and the suture catchmechanisms in a partially advanced position.

FIG. 6 is a perspective view of the embodiment of FIG. 3, as in FIG. 5,showing a casing attached to the device.

FIG. 7A is a plan view of the embodiment of FIG. 3, with the sutureclasp arms in an extended position.

FIG. 7B is a plan view as in FIG. 7A, but with the suture clasp armsretracted.

FIG. 8 is a cross-sectional view of the embodiment of FIG. 3, along aline VIII-VIII in FIG. 6.

FIG. 9 is a cross-sectional view of the embodiment of FIG. 3, along aline IX-IX in FIG. 7A.

FIG. 10 is a schematic representation an embodiment of a suturing devicepositioned in a passage through a valve.

FIG. 11 is a schematic representation as in FIG. 10 with suture clasparms positioned around first and second leaflets of the valve.

FIG. 12 is a schematic representation as in FIG. 11 with suture clasparms retracted.

FIG. 13 is a schematic representation as in FIG. 12 showing suture catchmechanisms engaging the suture clasp arms.

FIG. 14 is a schematic representation as in FIG. 13 showing the suturecatch mechanisms and suture portions retracted through the first andsecond leaflets.

FIG. 15 is a schematic representation as in FIG. 14 showing the sutureportions extending through the first and second leaflets and beingjoined by a knot.

FIG. 16 is a plan view of an embodiment of a suturing device system withtwo suturing devices and a suture joining device.

FIG. 17 is a plan view of an embodiment of a suturing device with asuture clasp arm in an extended position.

FIG. 18 is an enlarged perspective view of the distal end of thesuturing device of FIG. 17 with the suture clasp arm in an extendedposition.

FIG. 19 is a schematic representation an embodiment of a first suturingdevice positioned in a passage through a valve.

FIG. 20 is a schematic representation as in FIG. 19 with a suture clasparm positioned around a first leaflet of the valve.

FIG. 21 is a schematic representation as in FIG. 20 showing a suturecatch mechanism engaging the suture clasp arm.

FIG. 22 is a schematic representation as in FIG. 21 showing the suturecatch mechanism and a suture portion retracted through the firstleaflet.

FIG. 23 is a schematic representation as in FIG. 22 showing a secondsuturing device positioned in the passage through the valve.

FIG. 24 is a schematic representation as in FIG. 23 with the sutureclasp arm positioned around a second leaflet of the valve.

FIG. 25 is a schematic representation as in FIG. 24 showing a suturecatch mechanism engaging the suture clasp arm.

FIG. 26 is a schematic representation as in FIG. 25 showing the suturecatch mechanism and a suture portion retracted through the secondleaflet.

FIG. 27 is a schematic representation as in FIG. 26 showing the sutureportions extending through the first leaflet and the second leaflet andbeing joined by a first knot.

FIG. 28 is a plan view of an embodiment of a suturing device with asuture clasp arm in an extended position.

FIG. 29 is an enlarged perspective view of the distal end of thesuturing device of FIG. 28 with the suture clasp arm in an extendedposition.

FIG. 30 is a schematic representation of an embodiment of a firstsuturing device positioned in a passage through a valve.

FIG. 31 is a schematic representation as in FIG. 30 with a suture clasparm positioned around a first leaflet of the valve.

FIG. 32 is a schematic representation as in FIG. 31 showing a suturecatch mechanism engaging the suture clasp arm.

FIG. 33 is a schematic representation as in FIG. 32 showing the suturecatch mechanism and a suture portion retracted through the firstleaflet.

FIG. 34 is a schematic representation as in FIG. 33 showing a secondsuturing device positioned in the passage through the valve so as topermit a suture clasp arm to extend from the second suturing device.

FIG. 35 is a schematic representation as in FIG. 34 with the sutureclasp arm positioned around a second leaflet of the valve.

FIG. 36 is a schematic representation as in FIG. 35 showing a suturecatch mechanism engaging the suture clasp arm.

FIG. 37 is a schematic representation as in FIG. 36 showing the suturecatch mechanism and a suture portion retracted through the secondleaflet.

FIG. 38A is a plan view of an embodiment of a suturing device with twosuture clasp arms in an extended position.

FIG. 38B is an enlarged perspective view of the distal end of thesuturing device of FIG. 38A with the suture clasp arms in an extendedposition.

FIG. 39A is an enlarged perspective view of a distal end of anembodiment of a suturing device with two suture clasp arms in aretracted position.

FIG. 39B is an enlarged perspective view of the distal end of the suturedevice of FIG. 39A with the suture clasp arms in an extended position.

FIG. 40 is a schematic representation of an embodiment of a suturingdevice positioned in a passage through a valve.

FIG. 41 is a schematic representation as in FIG. 40 with a suture clasparm positioned around a first leaflet of the valve.

FIG. 42 is a schematic representation as in FIG. 41 showing a suturecatch mechanism engaging the suture clasp arm.

FIG. 43 is a schematic representation as in FIG. 42 showing the suturecatch mechanism and a suture portion retracted through the firstleaflet.

FIG. 44 is a schematic representation as in FIG. 43 showing the suturingdevice positioned in the passage through the valve so as to permit asecond suture clasp arm to extend from the suturing device.

FIG. 45 is a schematic representation as in FIG. 44 with the sutureclasp arm positioned around a second leaflet of the valve.

FIG. 46 is a schematic representation as in FIG. 45 showing a suturecatch mechanism engaging the suture clasp arm.

FIG. 47 is a schematic representation as in FIG. 46 showing the suturecatch mechanism and a suture portion retracted through the secondleaflet.

FIG. 48 is a schematic representation of an embodiment of a suturingdevice positioned in a passage through a valve with a first suture clasparm positioned around a first leaflet of the valve, and a second sutureclasp arm positioned around a second leaflet of the valve.

FIG. 49 is a schematic representation as in FIG. 47 or 48 showing thesuture portions extending through the first leaflet and the secondleaflet.

FIG. 50 is a schematic representation as in FIG. 49 showing the sutureportions extending through the first leaflet and the second leaflet andbeing joined by a first knot.

FIG. 51 is a schematic representation as in FIG. 50 showing the sutureportions extending through the first leaflet and the second leaflet andbeing joined by a first knot that has been pulled between the leaflets.

FIG. 52 is a schematic representation as in FIG. 51 showing the sutureportions extending through the first leaflet and the second leaflet andbeing joined by a first knot that has been pulled through one of theleaflets.

FIG. 53 is a schematic representation as in FIG. 49 showing the sutureportions extending through the first leaflet and the second leaflet andbeing joined by a first knot.

FIG. 54 illustrates placement of suture through a bicuspid valve near acentral portion of each leaflet.

FIG. 55 illustrates placement of three sutures through a bicuspid valvenear a central portion of each leaflet.

FIG. 56 illustrates placement of suture through a bicuspid valve atlocations spaced from the center of each leaflet.

FIG. 57 illustrates placement of suture through a bicuspid valve atmultiple locations spaced from the center of each leaflet.

FIG. 58 illustrates placement of suture through a tricuspid valve.

FIG. 59 illustrates placement of suture through a valve.

FIG. 60 illustrates placement of suture through a valve.

FIG. 61 illustrates placement of suture through chordae tendineae andmyocardium.

FIG. 62 is a schematic perspective view of an embodiment of a suturingdevice comprising two needles and a single arm having two suture mounts.

FIG. 63 is a schematic side view of the suturing device of FIG. 62 withthe arm extended and a protective member extended.

FIG. 64 is a schematic side view of the suturing device of FIGS. 62 and63 with a needle extended through the protective member.

FIG. 65 is a schematic representation of the suturing device of FIGS.62-64 positioned in a passage through a valve, such as the mitral valvevia transapical entry.

FIG. 66 is a schematic representation as in FIG. 65 with the armextended and the protective member extended.

FIG. 67 is a schematic representation as in FIG. 66 with the needleextended to pierce the valve and engage the arm.

FIG. 68 is a schematic partial cross-sectional view of the arm, needlesand valve of FIG. 67, taken along line 68-68.

FIG. 69 is a schematic partial cross-sectional view as in FIG. 68illustrating suture portions positioned through two locations in thevalve.

FIG. 70 is a schematic partial cross-sectional view as in FIG. 69 withthe suture portions secured together.

FIG. 71 is a schematic partial cross-sectional view of an arm, a needle,and a valve similar to FIG. 68, except the arm comprises a single suturemount and a single needle is illustrated.

FIG. 72 is a schematic partial cross-sectional view as in FIG. 71 with afirst suture portion positioned through the valve and a second arm and asecond needle illustrated in the process of placing a second sutureportion through a second location in the valve.

FIG. 73 is a schematic representation as in FIG. 72 with two sutureportions positioned through the valve and first ends of the sutureportions being secured together.

FIG. 74 is a schematic representation as in FIG. 73 with the secondsuture ends having been pulled to draw the secured first ends toward afirst side of the valve.

FIG. 75 is a schematic representation as in FIG. 74 with the secondsuture ends secured together.

FIG. 76 is a schematic perspective view of an embodiment of a suturingdevice comprising two needles and a single arm having two suture mounts,the two needles being located distally of the arm and configured forproximal movement to engage the arm.

FIG. 77 is a schematic representation of the suturing device of FIG. 76positioned within a passage of a valve, such as a mitral valve viaaccess through the inferior vena cava and the atrial septum.

FIG. 78 is a schematic representation as in FIG. 77 with the armextended and a protective member extended.

FIG. 79 is a schematic representation as in FIG. 78 with a needleadvanced through the protective member to engage the arm.

FIG. 80 is a schematic perspective view of a suturing device comprisingtwo needles and a single arm having two suture mounts, the two needlesbeing located proximally of the arm and configured for distal movementto engage the arm, and the arm having an extended position in which thearm is oriented at an angle of less than 90° relative to a longitudinalaxis of the suturing device.

FIG. 81 is a schematic representation of the suturing device of FIG. 80being positioned in a passage of a valve, such as a mitral valve such asby access through the inferior vena cava and the atrial septum, with thearm extended.

FIG. 82 is a schematic representation as in FIG. 81 with a protectivemember extended.

FIG. 83 is a schematic representation as in FIG. 82 with a needle beingadvanced through the protective member to engage the arm.

FIG. 84 is a schematic representation of suture placement locationsaccording to an embodiment.

FIG. 85 is a schematic representation of suture placement locationsaccording to an embodiment.

FIG. 86 is a schematic illustration of a human heart showing the chordaetendineae.

FIG. 87 is a schematic perspective view of an embodiment of a suturingdevice.

FIG. 88 is a schematic illustration of the suturing device of FIG. 87with six arms extended, with each arm having two suture mounts, and aprotective member extended.

FIG. 89 is a schematic representation of the suturing device of FIGS. 87and 88 positioned in a passage through a valve, such as the mitral valvevia transapical entry.

FIG. 90 is a schematic representation as in FIG. 89 with the armsextended.

FIG. 91 is a schematic representation as in FIG. 90 with the protectivemember extended.

FIG. 92 is a schematic representation as in FIG. 91 with the protectivemember positioned for movement of a needle through the protective memberto engage a first arm.

FIG. 93 is a schematic representation as in FIG. 92 with the protectivemember positioned for movement of a needle through the protective memberto engage a second arm.

FIG. 94 is a schematic representation as in FIG. 93, with sutureportions passed through 12 locations in the valve.

FIG. 95 is a plan view of an embodiment of a suturing device.

FIG. 96 is a schematic perspective view of an embodiment of a suturingdevice.

FIG. 97 is a schematic perspective view of an embodiment of a suturingdevice with a needle arm and two suture arms in an extended position.

FIG. 98 is a cross sectional view of an embodiment of a suture arm.

FIG. 99 is a cross sectional view of a section of the device of FIG. 95,showing the needle arm extended and aligned with an extended suture arm.

FIG. 100 is a top view of the device of FIG. 95, with the suture armsextended.

FIG. 101 is a cross sectional view of a distal section of an embodimentof a needle arm.

FIG. 102 is a top view of an embodiment of an extrusion.

FIG. 103 is a schematic representation of the suturing device of FIG. 95positioned in a passage through a valve, such as the mitral valve viatransapical entry.

FIG. 104 is a schematic representation as in FIG. 103 with the armsextended.

FIG. 105 is a schematic representation as in FIG. 104 with the armspositioned against the valve.

FIG. 106 is a schematic representation as in FIG. 105 with theprotective member extended.

FIG. 107 is a schematic representation as in FIG. 106 with theprotective member positioned for movement of a needle through theprotective member to engage a first arm.

FIG. 108 is a schematic representation as in FIG. 107 with the needleengaging a first arm.

FIG. 109 is a schematic representation as in FIG. 108 with the needlearm in a position between the two suture arms.

FIG. 110 is a schematic representation as in FIG. 109 with theprotective member positioned for movement of a needle through theprotective member to engage a second arm.

FIG. 111 is a schematic representation as in FIG. 110 with the needleengaging a second arm.

FIG. 112 is a schematic representation as in FIG. 111 with the needlearm in a position between the two suture arms.

FIG. 113 is a schematic representation as in FIG. 112, with sutureportions passed through two locations in the valve.

FIG. 114 is a schematic representation as in FIG. 112, showing thesuture portions passing through two locations in the valve and beingjoined by a first knot.

FIG. 115 is a schematic representation of a cross sectional side view ofa valve, showing a tube positioned around a suture passing through thevalve.

FIG. 116 is a schematic representation as in FIG. 115 showing two sutureends having been tightened and secured together.

FIG. 117 is a side view of a knot placement device.

FIG. 118 is a cross-sectional view of a knot and knot placement device.

FIG. 119 is a cross-sectional view of an embodiment of a knot and knotplacement device.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

Embodiments of suturing devices and methods for suturing biologicaltissue are disclosed herein. The suturing devices and their methods ofuse can be useful in a variety of procedures, such as treating (e.g.,closing) wounds and naturally or surgically created apertures orpassageways. For example, the suturing devices can be used to treat ananatomical valve, such as a heart valve, including heart valves that maybe weakened or stretched, or have other structural defects, such ascongenital defects, that cause them to close improperly. In someembodiments, one or more suturing devices can be used to treat or repairvalves, such as the tricuspid, pulmonary, mitral, and aortic valves, forexample. In some embodiments, one or more suturing devices can be usedto perform procedures such as edge-to-edge repair (like an Alfieritechnique), annuloplasty (with or without a ring or other implant),suturing of ventricular spaces, suturing of the chordae, suturing inother locations in the heart, replacement of the chordae tendineae,shortening of the chordae tendineae, patch application, leafletreshaping, and attachment of prosthetics, such as rings and biologicalor mechanical replacement valves, for example.

In some embodiments, the suturing devices can be used to close or reducea variety of other tissue openings, lumens, hollow organs or natural orsurgically created passageways in the body. In some embodiments, thesuturing devices can be used to suture prosthetics, synthetic materials,or implantable devices in the body. For example, the devices can be usedto suture a pledget within the body.

Access Methods and Devices

FIG. 1 illustrates an exemplifying use environment for suturing anaortic valve 4. Adaption of the devices and methods disclosed herein forsuturing a heart valve may also be made with respect to procedures forsuturing other bodily tissue and procedures for suturing prosthetics,synthetic materials, or implantable devices in the body. As depicted byFIG. 1, a guide wire 10 can be advanced through the aorta 2 to aposition at or near the aortic valve 4. The guide wire 10 can beadvanced into the aorta 2 through a subclavian artery (not shown). It isanticipated that the heart may be accessed through any of a variety ofpathways. For example, the heart may be accessed through the inferiorvena cava 3, the superior vena cava 5, or other vascular access. Withthe guide wire 10 in place, the physician can insert a sheath 12 to aposition at or near the aortic valve 4. This sheath 12 is typically asingle lumen catheter with a valve on its proximal end. The valve can beused, for example, to prevent extraneous bleed back or to introducemedication into the patient's body. A suturing device, such as thosedescribed further below, can then be advanced through the lumen of thesheath 12. In an alternative embodiment, the suturing device can beadvanced over the guide wire 10 and positioned at or near the aorticvalve 4 without the need to insert an introducer sheath 12.

FIG. 2A illustrates another exemplifying use environment for suturing amitral valve 8. As depicted by FIG. 2A, a guide wire 10 is advanced intothe left ventricle 6 of the heart through a puncture or incision 9 nearan apex 7 of the left ventricle 6. The heart may be accessed through alimited thoracotomy, small trocar puncture, or small catheter puncture.Other access paths may be used. The guide wire 10 can then be furtherpositioned at or near the mitral valve 8. With the guide wire 10 inplace, the physician can insert a sheath 12 to the left ventricle 6. Thesheath 12 can be placed at or near the mitral valve 8. The suturingdevice can then be advanced through the lumen of the sheath 12. In analternative embodiment, the suturing device can be advanced over theguide wire 10 and positioned at or near the mitral valve 8 without theneed to insert an introducer sheath 12.

FIG. 2B illustrates another exemplifying access route for suturing amitral valve 8. As depicted by FIG. 2B, a guide wire 10 is advancedthrough the inferior vena cava 11 into the right atrium 13 of the heartand through a puncture or an incision near the atrial septum 15 and intothe left atrium 17. The guide wire 10 can then be further positioned ator near the mitral valve 8. With the guide wire 10 in place, thephysician can insert a sheath 12 to the left atrium 17. The sheath 12can be placed at or near the mitral valve 8. The suturing device canthen be advanced through the lumen of the sheath 12. In an alternativeembodiment, the suturing device can be advanced over the guide wire 10and positioned at or near the mitral valve 8 without the needs to insertan introducer sheath 12. In some embodiments, for any of the accessroutes discussed above, the device can be inserted without a guide wire.

Embodiments of Suturing Devices and Methods, Such as for Suturing ValveLeaflets

FIGS. 3-9 illustrate an embodiment of a suturing device 100 that can beused to suture an anatomical valve, such as a heart valve. While thedevice 100 will be described with reference to suturing an anatomicalvalve, such as a heart valve, the device 100 could be used to sutureother biological tissue and implantable devices and materials. Thesuturing device 100 can comprise a distal assembly 102, one or moresuture clasp arms 104 (also labeled as 104A, 104B), and one or moresuture catch mechanisms 106 (referred to in some embodiments as“needles”). Each arm can have one or more suture portions 130 attachedto it. The suturing device 100 can further comprise an elongate body(not shown) to facilitate manipulation of the suture clasp arm(s) 104and the suture catch mechanism(s) 106 from a remote location. Forexample, the elongate body can comprise one or more lumens toaccommodate a length of suture, or one or more actuator rods formanipulating the suture clasp arm(s) 104 and the suture catchmechanism(s) 106, or both. In some embodiments, the distal assembly 102can comprise a portion of the elongate body.

The distal assembly 102 can comprise a proximal mount 108, distal mount110, a hub 112, and a casing 114 (FIG. 6). The proximal mount 108 can befixedly connected to the distal mount 110 by the casing 114. The hub 112can be positioned within the casing 114 for sliding movement between theproximal mount 108 and the distal mount 110.

The proximal mount 108 can be connected to the elongate body (notshown). Alternatively, a distal end of the elongate body can form or beintegrally formed with the proximal mount 108. In some embodiments, theelongate body can comprise the casing 114. The proximal mount 108 cancomprise one or more lumens 116, as shown in FIGS. 3 and 5.

The hub 112 can be fixedly connected to the suture catch mechanism(s)106 and an actuator rod 118. The actuator rod 118 can move through alumen 116 in the proximal mount 108. Accordingly, distal advancement ofthe actuator rod 118 causes distal advancement of the suture catchmechanism(s) 106. The hub 112 can comprise one or more lumens 120.

The suture clasp arm(s) 104 can be pivotally connected to the distalmount 110 such that the suture clasp arm(s) 104 can move between aretracted position, illustrated in FIGS. 3-4, and an extended position,illustrated in FIGS. 5-7A. Although the arms 104 of the device 100 thatis illustrated in FIGS. 3-9 pivot about a distal end of the arms 104,the arms 104 can pivot about a proximal end of the arms 104 in otherembodiments.

The suture clasp arm(s) 104 can be connected to an actuator rod 124,which can move through a lumen 116 in the proximal mount 108. The arm(s)104, the distal mount 110, and the rod 124 can be connected such thatdistal movement of the rod 124 causes the arm(s) 104 extend and proximalmovement of the rod 124 causes the arm(s) 104 to retract. In someembodiments, the arm(s) 104 can extend to a position that issubstantially perpendicular to their fully-retracted position. In otherembodiments, the arm(s) 104 can move less than 90° between thefully-retracted position and the fully-extended position.

The distal mount 110 can comprise one or more lumens 122 (FIG. 5) toallow movement of the suture catch mechanism(s) 106 through the distalmount 110. Additionally or alternatively, the one or more lumens 122 canaccommodate a length of suture, the actuator rod 124, or both.

The suture clasp arm(s) 104 can have suture clasps 126 to releasablyhold a suture portion 130. The suture catch mechanism(s) 106 can beadvanced to engage the suture portion(s) 130 held by the suture clasparms(s). Once the suture catch mechanism(s) 106 have engaged the sutureend portion(s) 130, the suture catch mechanism(s) 106 can be retractedto pull the suture ends from the suture claps 126.

In some embodiments, the suture clasps 126 can be positioned on thesuture clasp arm 104 such that the suture catch mechanism 106 retrievesthe suture end portion 130 retained in the suture clasp 126 while thesuture clasp arm 104 is at least partially retracted from itsfully-extended position. In some embodiments, the suture clasps 126 canbe positioned on the suture clasp arm 104 such that the suture catchmechanism 106 retrieves the suture end portion 130 retained in thesuture clasp 126 while the suture clasp arm 104 is fully retracted. Insome embodiments, the suture catch mechanism 106 can be advanced in acontinuously longitudinal direction to engage the suture clasp 126 ofthe suture clasp arm 104 while the suture clasp arm is fully retracted.In some embodiments, the suture clasp 126 can be located on aproximally-facing side of a suture clasp arm 104 that pivots about adistal end of the suture clasp arm. In some embodiments, the sutureclasp 126 can be located on a distally-facing side of a suture clasp arm104 pivots about a proximal end of the suture clasp arm.

In some embodiments, the suture clasp arm 104 can be configured toreceive a tissue-piercing portion of the corresponding suture catchmechanism 106. For example, in some embodiments, when the suture catchmechanism 106 is fully advanced, the tissue-piercing portion can befully received with the corresponding suture clasp arm 104. In someembodiments, the suture clasp arm 104 can receive the tissue-piercingportion of the suture catch mechanism 106 when the arm is at leastpartially closed. In some embodiments, suture clasp arm 104 can receivethe tissue-piercing portion of the suture catch mechanism 106 when thearm is fully retracted.

In some embodiments, the device 100 can comprise a recess 140 betweenthe suture clasp arm 104 and the distal mount 110, or other component ofthe distal assembly 102, when the suture clasp arm 104 is fullyretracted, as illustrated in FIG. 7B. In some embodiments, a tissueportion, such as a valve leaflet, can be received with the recess 140with the suture clasp arm 104 fully retracted and without damaging thetissue portion. In some embodiments, the tissue portion can be held inthe recess 140 by the suture clasp arm 104 while the suture clasp arm isfully retracted. In some embodiments, the tissue portion can be held inthe recess 140 by the suture clasp arm 104 while the suture clasp arm isat least partially retracted.

In some embodiments, the recess 140 can have a size and shape to receivea leaflet of a valve between the elongate body and the arm when the armis at least partially retracted without damaging the leaflet. In someembodiments, the recess 140 can have a size and shape to receive aleaflet of a valve between the elongate body and the arm when the arm isfully retracted without damaging the leaflet. In some embodiments, therecess 140 can have a size and shape to retain the leaflet between theelongate body and the arm when the arm is at least partially retractedwithout damaging the leaflet. In some embodiments, the recess 140 canhave a size and shape to retain the leaflet between the elongate bodyand the arm when the arm is fully retracted without damaging theleaflet.

In some embodiments, the device 100 can be manipulated with the sutureclasp arm(s) 104 in the extended position to place a tissue portion,such as a leaflet of a valve, between the suture clasp arm 104 and thedistal mount 110, as shown, for example, in FIG. 11. In someembodiments, the suture clasp arm 104 can be at least partially closedabout the tissue portion. In some embodiments, the suture clasp arm 104can be fully closed about the tissue portion. In some embodiments, thesuture clasp arm 104 can be at least partially retracted to securelyhold the tissue portion between the suture clasp arm 104 and the distalmount 110. In some embodiments, the suture clasp arm 104 can be moved tothe retracted position to securely hold the tissue portion between thesuture clasp arm 104 and the distal mount 110, as shown, for example, inFIG. 12. In some embodiments, the tissue portion is not damaged byclosing the suture clasp arm 104 about the issue portion or holding thetissue portion between the suture clasp arm 104 and the distal mount110.

With the tissue portion held between the arm 104 and the distal mount110, the corresponding suture catch mechanism 106 can be advanced toengage the suture portion 130 held by the suture clasp 126 of the arm104, as shown, for example, in FIG. 13. The suture portion 130 can thenbe drawn through the tissue portion by the suture catch mechanism 106,as shown, for example, in FIG. 14. In other embodiments, the suturecatch mechanism(s) 106 can be advanced toward the suture clasp arm(s)104 and retrieve the suture ends from the suture clasps 126 when thearm(s) 104 are in the extended position. In some embodiments, the suturecatch mechanism can be a needle.

In some embodiments, the distal assembly 102 can comprise a tube orconduit 128 to accommodate a suture and prevent damage to the suture byany component of the device 100. In some embodiments, the conduit 128extends through a lumen 116 in the proximal mount 108, a lumen 120 inthe distal mount 110, and a lumen 122 in the hub 112.

Further details regarding devices, structures, and methods that may beincorporated with the above embodiments are provided in U.S. Pat. No.7,090,686 and U.S. Patent Application Publication No. 2008/0269786,published on Oct. 30, 2008, all of which are hereby incorporated byreference herein in their entireties and are to be included as part ofthis specification. For example, in some embodiments having a pluralityof arms 106 and a plurality of suture catch mechanisms 106, each arm 104and each suture catch mechanism 106 of the device 100 can beindependently actuated to move individually between the retractedposition and the extended position.

FIGS. 10-15 illustrate a method for suturing an anatomical valveaccording to one embodiment. For example, the method can be used toperform edge-to-edge repair of a mitral valve. The distal end of asuturing device 100 can be positioned between leaflets 132 of a valve,as shown in FIG. 10. The device 100 can be advanced through thevasculature to the desired position using any of the access routesdiscussed above, and with or without a guide wire. For example, thedevice 100 can be advanced through the inferior vena cava into rightatrium and through the septum and positioned in the passage through themitral valve 8 (FIG. 2).

The suturing device 100 can be advanced to allow suture clasp arms 104to extend from the distal assembly 102. The suture clasp arms 104 canthen be extended and the device 100 can be retracted until the sutureclasp arms 104 extend around a first leaflet 132A and a second leaflet132B of the valve, as shown in FIG. 11.

Once the suture clasp arms 104 have been properly positioned around thefirst and second leaflets 132, the suture clasp arms 104 can beretracted to trap portions of the first and second leaflets 132, forexample between the suture clasp arms 104 and the distal mount 110 inthe recess 140, as illustrated in FIG. 12.

With the first and second leaflets 132 trapped the suture catchmechanisms 106 can be advanced from the distal assembly 102 to penetratethe first and second leaflets 132 and engage the suture portions 130held by the suture clasp arms 104, as illustrated in FIG. 13.

After the suture portions 130 have been engaged, the suture catchmechanisms 106 and engaged suture portions 130 are then retractedthrough the tissue of the first and second leaflets 132 into the distalassembly 102, as shown in FIG. 14. The suture clasp arms 104 can beextended to release the first and second leaflets 132. After the firstand second leaflets have been released, the device 100 can be advancedslightly so that the suture clasp arm 104 can be moved to the retractedposition without pinching the leaflets 132. The first suturing device100 can then be withdrawn from the valve.

As shown in FIG. 15, after the suturing device 100 has been withdrawn,the suture portions 130 extend from the leaflets 132. The sutureportions 130 can be pulled to draw the first leaflet 132A and the secondleaflet 132B towards one another. The suture portions 130 can then besecured together to limit movement of the leaflets 132A, 132B relativeto one another, as illustrated in FIG. 15 for example. In someembodiments, the sutures 130 can hold a portion of the leaflets 132A,132B in contact with one another. In other embodiments, the sutures 130merely hold the leaflets 132A, 132B in closer proximity to one anotherthan they had previously been. The suture portions 130 can be securedtogether by tying a knot 134 according to any known method or byapplying a knot 134, such as described in U.S. Patent Publication No.2007/0010829 A1, published Jan. 11, 2007, which is hereby incorporatedby reference herein in its entirety and is considered a part of thisspecification. The suture portions 130 can be secured together exteriorto the body or within the body. Any excess portion of sutures 130 can betrimmed. In some embodiments, one or more pledgets can be attached tothe suture portions 130, either before or after the knot is tied orapplied, and located distal and/or proximal to the knot 134.

FIG. 16 illustrates an embodiment of a system of devices that can beused to suture an anatomical valve, such as a heart valve. In someembodiments, the device can be included in a system of devices used tosuture an anatomical valve, such as the system illustrated in FIG. 16.The system of FIG. 16 includes two suturing devices 1100A,B, each ofwhich can comprise a distal assembly 1102A,B, a single suture clasp arm1104A,B, and a single suture catch mechanism 1106A,B (shown in FIGS. 21and 25). Further description herein of either suturing device 1100A or1100B may omit the letter A or B following the reference number, as itwill be appreciated that the components described can refer to eitherdevice.

The devices can be substantially similar but with at least the exceptionthat the single suture clasp arm 1104 of each suturing device isoriented generally opposite that of the other suturing device withrespect to their handles 1144. As illustrated, the devices have elongatebodies of differing lengths, but in other embodiments the elongatebodies can be substantially the same length. The system can also includea suture joining device 135, which can be used to apply a knot to two ormore suture ends or otherwise join two or more suture ends. Furtherdetails regarding the device for joining sutures are provided in U.S.Patent Application Publication No. 2011/0190793, published on Aug. 4,2011, which is hereby incorporated by reference herein in its entiretyand should be considered as part of this specification. Additionally,description of a device for joining sutures can be found below, and withrespect to FIGS. 117-119.

The suturing devices 1100A,B can comprise an elongate body 1142 tofacilitate manipulation of the suture clasp arm 1104 and the suturecatch mechanism (not visible) from a remote location. For example, theelongate body can comprise one or more lumens to accommodate a length ofsuture, or one or more actuator rods for manipulating the suture clasparm 1104 and the suture catch mechanism, or both.

The suturing devices 1100A,B can comprise a handle 1144 with one or moreactuators and/or pulls 1146 for moving the suture clasp arm 1104 and thesuture catch mechanism 1106. In various embodiments, the handle can beof different shapes and configures, such as the handles of FIG. 16, orthe handle illustrated in FIG. 17. Further details regarding handles andassociated components, including actuator rods, are provided in U.S.Patent Application Publication No. 2008/0269786, published on Oct. 30,2008, which is hereby incorporated by reference herein in its entiretyand is considered a part of this specification.

FIG. 18 illustrates a distal assembly 1102A of one of the suturingdevices 1100A with the suture clasp arm 1104A in an extended position.In some embodiments, the suture clasp arm 1104A can pivot about an axislocated at a distal end of the suture clasp arm 1104A to move the sutureclasp arm 1104A from a retracted position to an extended position, asillustrated in FIG. 18. The same description can apply to the othersuturing device 1100B.

FIGS. 19-27 illustrate a method according to one embodiment for suturingan anatomical valve, such as edge-to-edge repair of a mitral valve.Although the illustrated method involves two devices 1100A,B, eachhaving a single suture clasp arm 1104 and a single suture catchmechanism 1106, the illustrated method can also be practiced using asingle suturing device 1100 having more than one arm 1104 and more thanone suture catch mechanism 1106, as described further below.

The distal end of a first suturing device 1100A can be positionedbetween leaflets 132 of a valve, as shown in FIG. 19. The device 1100Acan be advanced through the vasculature to the desired position usingany of the access routes discussed above, and with or without a guidewire. For example, the device 1100A can be advanced through the inferiorvena cava into right atrium and through the septum and positioned in thepassage through the mitral valve 8 (FIG. 2).

The suturing device 1100A can be advanced to allow a suture clasp arm1104A to extend from the distal assembly 1102A. The suture clasp arm1104A can then be extended and the device 1100A can be retracted untilthe suture clasp arm 1104A extends around a first leaflet 132A of thevalve, as shown in FIG. 20.

Once the suture clasp arm 1104A has been properly positioned around thefirst leaflet 132A, the suture catch mechanism 1106A can be advancedfrom the distal assembly 1102A to penetrate the first leaflet 132A andengage the suture portion 130A held by the suture clasp arm 1104A, asillustrated in FIG. 21. In some embodiments, the suture clasp arm 1104Acan be moved to the retracted position to securely hold a portion of thefirst leaflet 132A between the arm 1104A and the elongate body, forexample, before the suture catch mechanism 1106A is advanced through thefirst leaflet 132A to engage the suture end, as described above.

After the suture portion 130A has been engaged, the suture catchmechanism 1106A and engaged suture portion 130A are then retractedthrough the tissue of the first leaflet 132A into the distal assembly1102A, as shown in FIG. 22. The device 1100A can be advanced slightly sothat the suture clasp arm 1104A can be moved to the retracted positionwithout pinching the first leaflet 132A. The first suturing device 1100Acan then be withdrawn from the valve.

A second suturing device 1100B can then be advanced into the heart andpositioned between the leaflets 132A, 132B of the valve, as shown inFIG. 23. The suture clasp arm 1104B can then be extended and the device1100B can be advanced such that the suture clasp arm 1104B extendsaround the tip of the second leaflet 132B, as shown in FIG. 24.

Once the suture clasp arm 1104B has been properly positioned around thesecond leaflet 132B, the suture catch mechanism 1106B can be advancedfrom the distal assembly 1102B to penetrate the second leaflet 132B andengage the suture portion 130B held by the suture clasp arm 1104B, asillustrated in FIG. 25. As noted above with respect to the first leaflet132A, in some embodiments, the suture clasp arm 1104B can be moved tothe retracted position to securely hold a portion of the second leaflet132B between the arm 1104B and the distal assembly 1102B before thesuture catch mechanism 1106B is advanced through the second leaflet 132Bto engage the suture portion 130B.

After the suture portion 130B has been engaged, the suture catchmechanism 1106B and engaged suture portion 130B are then retractedthrough the tissue of the second leaflet 132B into the distal assembly1102B, as illustrated in FIG. 26. The suture clasp arm 1104B can then beclosed after slightly advancing the device 1100B to avoid pinching thesecond leaflet 132B as the arm 1104B is closed. Once the suture clasparm 1104B is closed, the suturing device 1100B can be withdrawn from thepatient's heart.

As shown in FIG. 27, after the suturing device 1100B has been withdrawn,the suture portions 130A,B will extend proximally from the leaflets132A, 132B. The suture portions 130A,B can then be secured together, asillustrated in FIG. 27, by tying a knot 134 according to any knownmethod or by applying a knot 134. In some embodiments, one or morepledgets can be attached to the suture portions 130A,B, either before orafter the knot is tied or applied, and located distal and/or proximal tothe knot 134. The suture portions 130A,B can be secured togetherexterior to the body or within the body. Any excess portion of sutures130 can be trimmed. The suture portions 130A,B can then be pulled todraw the first leaflet 132A and the second leaflet 132B towards oneanother. A second knot can then be tied or applied to the sutures 130 tolimit movement of the leaflets 132A, 132B relative to one another, asdescribed above. In some embodiments, the sutures 130 can hold a portionof the leaflets 132A, 132B in contact with one another. In otherembodiments, the sutures 130 merely hold the leaflets 132A, 132B incloser proximity to one another than they had previously been.

When a device having a plurality of arms and a plurality of suture catchmechanisms is used, the device can be configured to place a singlesuture 130 through both the first leaflet 132A and the second leaflet132B. The single suture 130 can be placed through the first and secondleaflets 132 either simultaneously or sequentially. In some embodiments,the suture portions 130 can be pulled to draw the first leaflet 132A andthe second leaflet 132B towards one another without applying a knot tothe suture 130 beforehand. Accordingly, a single knot 134 can be appliedto the suture 130 to hold the leaflets 132A, 132B in proximity to oneanother.

FIGS. 28 and 29 illustrate an embodiment of a suturing device 2100A thatcan be used to suture an anatomical valve, such as a heart valve. Thesuture device 2100A illustrated in FIGS. 28 and 29 is similar is somerespects to the suturing devices illustrated and described above. Forexample, the suturing device 2100A of FIGS. 28 and 29, like the suturingdevice 1100 of FIGS. 17 and 18, can comprise a distal assembly 2102A, asingle suture clasp arm 2104A, and a single suture catch mechanism2106A.

As illustrated in FIGS. 28 and 29, the suturing device 2100A cancomprise an elongate body 2142A to facilitate manipulation of the sutureclasp arm 2104A and the suture catch mechanism 2106A from a remotelocation. For example, the elongate body can comprise one or more lumensto accommodate a length of suture, or one or more actuator rods formanipulating the suture clasp arm 2104A and the suture catch mechanism2106A, or both. The suturing device 2100A can comprise a handle with oneor more actuators and/or pulls 2146A for moving the suture clasp arm2104A and the suture catch mechanism 2106A. Further details regardinghandles and associated components, including actuator rods, are providedin U.S. Patent Application Publication No. 2008/0269786, published onOct. 30, 2008, which is hereby incorporated by reference herein in itsentirety and is considered a part of this specification.

In some embodiments, the suture clasp arm 2104A can pivot about an axislocated at a proximal end of the suture clasp arm 2104A when the sutureclasp arm 2104A is in a retracted position, as illustrated in FIGS. 28and 29.

A method of suturing anatomical valves, such as edge-to-edge repair of amitral valve, is illustrated in FIGS. 30-37. Although the illustratedmethod involves two devices 2100A,B, each having a single suture clasparm 2104A,B and a single suture catch mechanism 2106A,B, the illustratedmethod can also be practiced using a device 2100 having more than onearm 2104 and more than one suture catch mechanism 2106, as discussedabove, for example.

The distal end of a first suturing device 2100A can be positionedbetween leaflets 132 of a valve, as shown in FIG. 30. The device 2100Acan be advanced through the vasculature to the desired position usingany of the access routes discussed above, and with or without a guidewire. For example, the device 2100A can be advanced through a subclavianartery into the aorta to position the device 2100A in the passagethrough the aortic valve 4 (FIG. 1). Alternatively, the device 2100A canbe inserted through a puncture or small incision 9 in the heart toposition the device 2100A in the passage through the mitral valve 8, asshown in FIG. 2. Such a puncture can be located at or near the apex ofthe heart 7.

As illustrated in FIG. 30, the suturing device 2100A can be positionedto allow a suture clasp arm 2104A to extend from the distal assembly2102A. The suture clasp arm 2104A can then be extended and the device2100A can be advanced until the suture clasp arm 2104A extends around afirst leaflet 132A of the valve, as shown in FIG. 31.

Once the suture clasp arm 2104A has been properly positioned around thefirst leaflet 132A, the suture catch mechanism 2106A can be advancedfrom the distal assembly 2102A to penetrate the first leaflet 132A andengage the suture portion 130A held by the suture clasp arm 2104A, asillustrated in FIG. 32. In some embodiments, the suture clasp arm 2104Acan be moved to the retracted position to securely hold a portion of thefirst leaflet 132A between the arm 2104A and the distal assembly 2102Abefore the suture catch mechanism 2106A is advanced through the firstleaflet 132A to engage the suture end, as described above, for example.

As shown in FIG. 33, once the suture portion 130A has been engaged, thesuture catch mechanism 2106A and engaged suture portion 130A are thenretracted through the tissue of the first leaflet 132A into the distalassembly 2102A. The device 2100A can be retracted slightly so that thesuture clasp arm 2104A can be moved to the retracted position withoutpinching the first leaflet 132A. The first suturing device 2100A canthen be withdrawn from the valve.

A second suturing device 2100B can then be advanced into the heart andpositioned between the leaflets 132A, 132B of the valve, as shown inFIG. 34. The suture clasp arm 2104B can then be extended and the device2100B can be advanced such that the suture clasp arm 2104B extendsaround the tip of the second leaflet 132B, as shown in FIG. 35.

In the illustrated embodiment, once the suture clasp arm 2104B has beenproperly positioned around the second leaflet 132B, the suture catchmechanism 2106B can be advanced from the distal assembly 2102B topenetrate the second leaflet 132B and engage the suture portion 130Bheld by the suture clasp arm 2104B, as illustrated in FIG. 36. As notedabove with respect to the first leaflet 132A, in some embodiments, thesuture clasp arm 2104B can be moved to the retracted position tosecurely hold a portion of the second leaflet 132B between the arm 2104Band the distal assembly 2102B before the suture catch mechanism 2106B isadvanced through the second leaflet 132B to engage the suture portion130B.

After the suture portion 130B has been engaged, the suture catchmechanism 2106B and engaged suture portion 130B are then retracteddistally through the tissue of the second leaflet 132B into the distalassembly 2102B, as illustrated in FIG. 37. The suture clasp arm 2104Bcan then be closed after slightly retracting the device 2100B to avoidpinching the second leaflet 132B. Once the suture clasp arm 2104B isclosed, the suturing device 2100B can be withdrawn from the patient'sheart.

In some embodiments, a suturing device 3100 can have a plurality of arms3104. In some embodiments, the arms can be spaced at varying intervalsaround the circumference of the elongate body. In some embodiments, aplurality of arms can extend from one side of the elongate body and acorresponding plurality of arms can extend from an opposite side of theelongate body. FIGS. 38A and 38B illustrate a view of a suturing device3100 having two arms 3104A,B. As illustrated, the arms are spacedapproximately 180 degrees from each other about the elongate body 3142.In some embodiments, the suturing device can have two suture catchmechanisms 3106A,B, one associated with each arm. The device can bedesigned so that the plurality of arms is deployed simultaneously, andthat the plurality of suture catch mechanisms is deployedsimultaneously. Alternatively, the device can be designed so that eacharm and each suture catch mechanism can be deployed separately. In someembodiments, the suturing device can be used as a system with a suturejoining device 135, as discussed above with respect to FIG. 16. Manyaspects of the suturing device can function substantially the same asaspects of the device described with respect to FIGS. 28-37. Unlessdiscussed otherwise, components can be considered to have substantiallythe same function and operate in substantially the same manner assimilarly labeled components described with respect to FIGS. 28-37. As anon-limiting example, the device can comprise a distal assembly 3102 anda handle with one or more actuators and/or pulls 3146 for moving thesuture clasp arms 3104 and deploying the suture catch mechanisms 3106.

In some embodiments, a suturing device can have a distal assembly 3102′as seen in FIGS. 39A and 39B. FIG. 39A illustrates a device with twosuture arms 3104A′,B′ that are in a retracted position. In FIG. 39B,both suture arms 3104A′,B′ are in an extended position, and suture catchmechanisms 3106A′,B′ have extended through the corresponding arms atsuture clasps 3126A′,B′. In some embodiments, the arms can extend andretract simultaneously or in sequence, and in some embodiments thesuture catch mechanisms can extend and retract simultaneously or insequence. Also as illustrated, in some embodiments a suturing device cancomprise a tapered portion 3113′ at a distal end and/or a guide wirelumen 3111′ that can be used if the device advances over a guide wire.

A method of suturing anatomical valves, such as edge-to-edge repair of amitral valve, with a dual arm suturing device is illustrated in FIGS.40-47. The method is described with reference to the suturing device3100 of FIGS. 38A and 38B, but any dual arm suturing device can be used,such as one with a distal assembly as described with reference to FIGS.39A and 39B. The suturing device 3100 can be advanced to a desiredposition between leaflets 132 of a valve, as shown in FIG. 40, by any ofthe methods discussed above with reference to the method of FIGS. 30-37,and with or without a guide wire. In the embodiment illustrated, thesuturing device 3100 may be delivered transapically into the leftventricle, and delivered so that the distal end of the device extendsthrough the mitral valve into the left atrium. However, the device canalso be designed for an approach to pass through the septum between theright and left atrium, through the mitral valve and into the leftventricle. The locations and configurations of the suture clasp arms3104 and the suture catch mechanisms 3106 may be appropriately designedbased on the desired method of approach and based on the desiredlocation to be sutured. For example, while the arms 3104 in theembodiment of FIG. 40 are shown proximal to the suture catch mechanisms3106, in a different device the arms 3104 may be located distal to thesuture catch mechanisms.

For suturing a mitral valve as shown in FIG. 40, the device can bepositioned such that at least one of the suture clasp arms, a first arm3104A, can be extended from the device, and the device can be advanceduntil the first arm 3104A extends around or adjacent to a first leafletof the valve 132A, as shown in FIG. 41. Accordingly, when suturing themitral valve, the arm 3104A can be positioned on a proximal side, or theventricular side, of the leaflet 132A. The arm 3104A carries an end of asuture portion 130A. FIG. 40 shows arm 3104A being deployedindependently of arm 3104B, but in other embodiments, both arms can bedeployed together.

As described with respect to FIG. 32, once the first suture clasp arm3104A is properly positioned, the suture catch mechanism 3106A can beadvanced from the distal assembly 3102 from a location distal to theleaflet 132A (or on the atrial side of the leaflet, for a mitral valveprocedure) to penetrate the first leaflet 132A and engage the sutureportion 130A held by the first suture clasp arm 3104A, as illustrated inFIG. 42. In some embodiments, the first suture clasp arm 3104A can bemoved to the retracted position to securely hold a portion of the firstleaflet 132A between the first arm 3104A and the distal assembly 3102before the suture catch mechanism 3106A is advanced through the firstleaflet 132A to engage the suture end.

As shown in FIG. 43, once the suture portion 130A has been engaged, thesuture catch mechanism 3106A and engaged suture portion 130A are thenretracted through the tissue of the first leaflet 132A into the distalassembly 3102. The device 3100 can be retracted slightly so that thefirst suture clasp arm 3104A can be moved to the retracted positionwithout pinching the first leaflet 132A, as illustrated in FIG. 44. Thesuturing device 3100 can then be retracted at least far enough to allowthe second suture clasp arm 3104B to extend from the device.

As illustrated in FIG. 45, the second suture clasp arm 3104B can extendfrom the device and the device can be advanced, and moved laterally ifnecessary, such that the second suture clasp arm 3104B extends aroundthe tip of the second leaflet 132B. In some embodiments, the secondsuture clasp arm 3104B can extend before or while the first arm 3104A isretracted.

As with the first arm 3104A, once the second suture clasp arm 3104B hasbeen properly positioned around the second leaflet 132B, a suture catchmechanism 3106B can be advanced from the distal assembly 3102 topenetrate the second leaflet 132B and engage the suture portion 130Bheld by the suture clasp arm 3104B, as illustrated in FIG. 46. As notedabove with respect to the first leaflet 132A, in some embodiments, thesuture clasp arm 3104B can be moved to the retracted position tosecurely hold a portion of the second leaflet 132B between the arm 3104Band the distal assembly 3102 before the suture catch mechanism 3106B isadvanced through the second leaflet 132B to engage the suture portion130B. In some embodiments, the suture catch mechanism can be the samecatch mechanism as the one used with the first arm 104A. In theillustrated embodiment, the suture portions 130A,B are portions ofseparate sutures, but in some embodiments the suture portions 130A,B canbe portions of the same suture.

After the suture portion 130B has been engaged, the suture catchmechanism 3106B and engaged suture portion 130B are then retracteddistally through the tissue of the second leaflet 132B into the distalassembly 3102, as illustrated in FIG. 47. The suture clasp arm 3104B canthen be closed after slightly retracting the device 3100 to avoidpinching the second leaflet 132B. Once the suture clasp arm 3104B isclosed, the suturing device 3100 can be withdrawn from the patient'sheart.

In some embodiments, the first suture clasp arm 3104A and the secondsuture clasp arm 3104B can both be extended from the device atsubstantially the same time and extend around opposite tips of theleaflets 132A, 132B, as illustrated in FIG. 48. In other embodiments,the clasp arms can be extended at the same time, but with one havingextended before the other. Also as illustrated, suture catch mechanismscan be advanced through the suture clasp arms 3104A, 3104B atsubstantially the same time. In other embodiments, both clasp arms canextend around the leaflets but the suture catch mechanisms can advanceone before the other.

Methods for Drawing Sutured Leaflets Closer Together

As shown in FIG. 49, after one or more of the suturing devices has beenwithdrawn, the suture portions 130A, 130B will extend proximally fromthe leaflets 132A, 132B. The methods for drawing sutured leaflets closertogether described herein with respect to FIGS. 49-59 can apply equallyto orientations, such as that of FIG. 15, reflected in embodiments wheresuturing devices take different access routes to a valve. Additionally,for all methods described herein, one or more pledgets can be attachedto the suture portion(s), either before or after a knot is tied orapplied, and located distal and/or proximal to the knot. FIG. 49illustrates four strands of suture portion extending from the leaflets,which can comprise either a single suture if the arms described abovewere carrying the same suture, or two separate sutures, one sutured toeach leaflet, if the arms described above were carrying their ownsuture. If the four strands illustrated in FIG. 49 are part of the samesuture, the ends of the suture may be pulled from outside of the body toapply tension to the suture and draw the leaflets together. The sutureportions can be secured together by tying a knot, applying a knot orotherwise joining the suture portions together according to knownmethods.

In some embodiments, for example where two separate sutures are suturedto the leaflets 132A and 132B, two ends of the separate sutures can thenbe secured together, as illustrated in FIG. 50, by tying a knot 134according to any known method or by applying a knot 134. The sutureportions 130A,B can be secured together exterior to the body or withinthe body. Any excess portion of sutures can be trimmed. In someembodiments, the free ends of the suture portions 130A,B can then bepulled to draw the first leaflet 132A and the second leaflet 132Btowards one another, with the knot or joined portion between theleaflets as illustrated in FIG. 51. A second knot can then be tied orapplied to the sutures 130A,B to limit movement of the leaflets 132A,Brelative to each other.

In some embodiments, after the knot has 134 has been applied andpositioned as shown in FIG. 51, just one of the free ends can be pulledinitially, drawing the knot through one of the leaflets and out of thebody, as illustrated in FIG. 52. This leaves a single suture passingthrough the leaflets. The two portions of the single suture can then bepulled to draw the first leaflet and second leaflet towards each otherand a second knot can be tied or applied to the two portions.

In some embodiments, where two separate sutures and four suture portionsextend from the leaflets, rather than initially securing two ends of thesuture portions together, all four portions can be secured togetheraccording to any of the methods discussed herein, as illustrated in FIG.53.

In some embodiments, where a single suture is positioned through theleaflets or a pair of sutures is positioned through the leaflets such asshown in FIGS. 51 and 52, one end of the suture can be secured to asecond suture, the second suture can be drawn through the leaflets bypulling on the first suture, and a knot can be tied or applied to thesecond suture. In this embodiment, a first suture placed by the suturingdevice can be utilized to guide a second suture or another piece ofmaterial across the leaflets. The second suture or other piece ofmaterial is, in some embodiments, thicker or stronger than the firstsuture. In some embodiments, the second piece of material has a greatersurface area to engage tissue, which can advantageously minimizedissection of tissue.

To accomplish placement of the second suture or additional piece ofmaterial in the place of the first suture, the second suture or otherpiece of material can be attached to one end or a first portion of thealready placed suture. The first suture can be attached to the secondsuture or other piece of material by forming a knot by any known manner,or by otherwise joining them, for example, by welding the materialtogether.

Thereafter, the other end or a second portion of the first suture can bepulled away from the leaflets. This causes the thicker suture to bedrawn through the tissue and across the leaflets into the same positionwhere the first suture(s) was placed. After the thicker suture has beenpulled across the leaflets, the ends of the second suture or piece ofmaterial will in one embodiment be outside of the body.

The second suture or other piece of material can be detached from theoriginal suture, and if the original suture has not already been removedfrom the patient, it can then be removed. With the ends of the secondsuture or other piece of material extending from the opening and out ofthe patient, that suture or material can be secured together by tying aknot according to any known method or by applying a knot, such asdescribed in U.S. Patent Publication No. 2007/0010829 A1, published Jan.11, 2007, which is hereby incorporated by reference herein in itsentirety and is considered a part of this specification.

In some embodiments, once the suture or other material is used to drawthe leaflets closer together and the knot is made or applied, the sutureor other material can hold a portion of the leaflets 132A, 132B incontact with one another. In other embodiments, the suture or othermaterial merely hold the leaflets 132A, 132B in closer proximity to oneanother than they had previously been.

When a suturing device having two arms 3104 and two suture catchmechanisms 3106 is used, as discussed with reference to FIGS. 38A-48,the device 3100 can be configured to place a single suture 130 throughboth the first leaflet 132A and the second leaflet 132B, eithersimultaneously or sequentially. In some such embodiments, the sutureportions 130 can be pulled to draw the first leaflet 132A and the secondleaflet 132B towards one another without applying a knot to the suture130 beforehand. Accordingly, a single knot 134 can be applied to thesuture 130 to hold the leaflets 132A, 132B in proximity to one another.

The suture or sutures 130 can be placed through the leaflets 132 atlocations selected by the physician to treat a problem of a particularvalve. For example, in some embodiments, a suture or sutures 130 can bepassed through the leaflets 132 at locations in or near a central regionof the leaflets 132, as illustrated in FIG. 54. FIG. 55 illustrates anembodiment in which three sutures 130 have been passed through theleaflets 132 in a central region of the leaflets. In some embodiments, asuture or sutures 130 can be passed through a portion of the leaflets132 that is in proximity to a periphery of the valve, as illustrated inFIG. 56. In some embodiments, sutures 130 can be applied to multiplelocations between two leaflets 132, as illustrated in FIG. 57. In someembodiments, sutures 130 can be applied to multiple locations betweenmore than two leaflets 132, as illustrated in FIG. 58 with respect to atricuspid valve.

FIGS. 59 and 60 illustrate other manners of placing suture throughleaflets of a valve. In some embodiments, suture can be placed as shownin FIG. 59 or 60 using the devices illustrated in FIGS. 17-18 and 28-29.The devices can be introduced through the same or different accessroutes. For example, one device can be introduced to the heart throughthe vasculature while another device is introduced transapically. Insome embodiments, a first suture can be placed through a first leafletby a first device 1100 as illustrated in FIGS. 19-22 and a second suturecan be placed through a second leaflet by a second device 2100 asillustrated in FIGS. 30-33. The second suture can be placed before thefirst suture in some embodiments. In embodiments involving the placementof multiple sutures, the multiple sutures can be joined with a singleknot or with multiple knots. Further information regarding devices andmethods for placing suture as shown in FIGS. 59 and 60 is provided inU.S. Patent Application Publication No. 2008/0269786, published on Oct.30, 2008, and, in particular, the embodiments described in associationwith FIGS. 10I-L, 27-28B, 36-39A-K.

Devices and Methods for Techniques Other than Valve Repair

The devices and methods described and referenced herein can be used toperform other techniques for valve repair. For example, the devices andmethods described above can be used to apply a suture to one or more ofthe chordae tendineae 136 and myocardium 138, as illustrated in FIG. 61,to restore tension to chordae tendineae that have been come elongated.In some embodiments, the applied suture can be used as a guide suture todeliver a second suture or other material (e.g. artificial chordae)through the chordae, as described above. The devices and methodsdescribed above can be used to suture a patch to natural orsurgically-created openings in leaflets. The devices and methodsdescribed above can be used to attach a ring around the outside of themalfunctioning valve. The devices and methods described above can beused to suture prosthetics to the heart.

Further Embodiments of Additional Suturing Devices, Such as for Suturinga Base of A Valve

FIG. 62 is a schematic perspective view of an exemplifying embodiment ofa distal end 4102 of a suturing device 4100 that can be used to suturean anatomical valve, such as a heart valve. The suturing device 4100 cancomprise two suture catch mechanisms 4106 and a single arm 4104 locatedin proximity to a distal end 4102 of an elongate body 4142. The arm isconfigured for movement between a retracted position and an extendedposition. In some embodiments, the arm can be moved between theretracted and extended position by rotation around an end of the armthat is pivotally coupled to the elongate body 4142. In otherembodiments, the arms can be advanced along their length out of anopening in the elongate body 4142, as shown and described in U.S. Pat.No. 6,911,034, issued on Jun. 28, 2005, which is hereby incorporated byreference herein in its entirety and is considered a part of thisspecification.

In the embodiment of FIG. 62, the single arm 4104 comprises two sutureclasps or mounts 4126 in proximity to a free end of the arm 4104. Insome embodiments, the arm 4104 can comprise more than two suture clasps4126. The suture clasps 4126 can be located at or near the free end ofthe arm 4104. The arm 4104 of this embodiment is sufficiently long to beable to position the suture clasps 4126 at or near a base of a heartvalve, such as the mitral valve for example. The arm 4104 illustrated inFIG. 62 extends generally orthogonally to a longitudinal axis of theelongate body 4142.

The suture clasps 4126 of the arm 4104 are spaced from one another by adistance. The distance between the suture clasps can vary amongdifferent embodiments. The magnitude of separation corresponds generallyto the magnitude of separation between locations of suture placement inthe tissue. The magnitude of separation between the suture clasps can bevaried depending on the desired use.

In the exemplifying embodiment of FIG. 62, the two suture catchmechanisms 4106 are illustrated as needles. The needles can be operatedsimultaneously in some embodiments and sequentially in otherembodiments. As described in connection with the preceding embodiments,the suture catch mechanisms can be deployed and retracted to retrievesuture portions 130 that are releasably held by the arm 4104 (see FIGS.65-68). Although the embodiment illustrated in FIG. 62 comprises twoneedles, the suturing device can comprise more than two needles in someembodiments. The arm(s) 4104 will typically be configured to have thesame number of suture mounts as the number of suture catch mechanisms,with each suture mount releasably carrying a suture portion.

The exemplifying embodiment of FIG. 62 also includes protective members4107 (also described herein as “needle arms”). The protective members4107 are configured to inhibit contact between a distal end of thesuture catch mechanisms and surrounding tissue during at least a portionof the deployment of the needles. In general, the protective membersprotect the tissue surrounding the suturing device 4100 from damage bythe suture catch mechanisms 4106 as the suture catch mechanisms aremoved from their retracted positions to the locations of the valve wherethe suture portions are to be passed through the valve.

As illustrated in FIG. 62, in embodiments comprising a plurality ofsuture catch mechanisms, the suturing device can have a separateprotective member corresponding to each suture catch mechanism. In otherembodiments, the suturing device can have a single protective memberconfigured to protect surrounding tissue from two or more suture catchmechanisms at the same time.

In some embodiments, such as that of FIG. 62, the protective members canhave a generally sleeve-like configuration to generally surround thesuture catch mechanisms 4106. The protective members can entirelysurround a circumference of the suture catch mechanisms in someembodiments. In other embodiments, the protective members can merelypartially surround a circumference of the suture catch mechanisms. Forexample, whether surrounding one or more suture catch mechanisms, theprotective member can in some embodiments have a generally U-shapedcross-section with the opening in the protective member being orientedto face the elongate body when the protective member is extended. Insome embodiments, a protective member can completely surround more thanone needle in a single lumen.

The protective members preferably extend over the distal ends of thesuture catch mechanisms, extend beyond the distal ends of the suturecatch mechanisms, or both.

The protective members 4107 of the exemplifying embodiment of FIG. 62can be moved between a retracted position and an extended position. Asillustrated in FIG. 63, the protective member 4107 can be extended fromthe elongate body 4142 in advance of the corresponding suture catchmechanism 4106 such that the distal end of the suture catch mechanism isnot exposed to the surrounding tissue as the suture catch mechanism ismoved toward the location of the valve to be sutured.

In some embodiments, the suture catch mechanism 4106 can be advancedtoward the location for suture placement and the arm 4104 once theprotective member 4107 has been advanced to the location for sutureplacement, as illustrated in FIG. 64 for example. After the suture catchmechanism has retrieved the suture portion from the arm as discussed inconnection with the foregoing embodiments, the suture catch mechanism4106 and the protective member 4107 can be retracted into the elongatebody 4142 with the suture portion 130. The protective members can beplaced generally at the location to be sutured before the needles aremoved from their retracted positions in some embodiments. In otherembodiments, the needles can be moved toward their deployed positionswhile the protective members are extended. For example, the distal endof the protective member can be located beyond a distal end of thecorresponding needle as both are advanced. In this example, once thedistal end of the protective member has been placed generally at thelocation to be sutured, the distal end of the needle can then beadvanced beyond the distal end of the protective member to penetrate thetissue of the valve.

When a plurality of suture catch mechanisms 4106 are advanced toward thearm 4104 simultaneously, the protective members 4107 may also beadvanced simultaneously. Alternatively, the protective members 4107 maybe sequentially advanced even though the suture catch mechanisms areadvanced simultaneously. The protective members 4107 can, in someembodiments, be advanced simultaneously, although the suture catchmechanisms are advanced sequentially. The use of multiple suture catchmechanisms per arm, as well as the use of the protective member, can beincorporated into any of the devices described herein, including theedge-to-edge repair devices previously described.

FIGS. 65-70 schematically illustrate use of the suturing device 4100 ofFIGS. 62-64 according to an embodiment. The valve shown in FIGS. 65-70can be a mitral valve 8 and the suturing device can be inserted into thevalve via a transapical opening, or using any of the access routesdiscussed above, with or without a guide wire. Although reference ismade to the mitral valve in connection with FIGS. 65-70, the descriptioncan apply to valves other than the mitral valve.

As illustrated in FIG. 65, the distal assembly 4102 of the suturingdevice 4100 is advanced into the passage through the mitral valve 8. Thedistal assembly 4102 is advanced sufficiently far through the passage topermit the arm 4104 to be opened without damaging surrounding tissue.Once the arm 4104 is extended, the suturing device is retracted throughthe passage such that the free end of the arm 4104 is adjacent a base ofthe valve as illustrated in FIG. 66. A protective member 4107 is thenadvanced to position the distal end of the protective member 4107 at ornear a base of the valve. A leaflet 132 of the valve can be positedbetween the arm 4104 and the protective member in some embodiments, suchas that illustrated in FIG. 66. Once the protective member has beenadvanced, the suture catch mechanism 4106 is advanced through the tissueof the valve to engage the arm 4104 as illustrated in FIG. 67.

FIG. 68 is a schematic a partial cross-sectional view of the arm 4104,the suture catch mechanisms 4106, and the valve of FIG. 67 taken alongline 68-68. Although FIG. 68 illustrates both needles positioned throughthe tissue at the same time, such an arrangement may not occur in someembodiments, for example when a first needle is deployed and retractedbefore a second need is deployed.

The suture catch mechanisms 4106 are retracted through the tissue withthe suture portions 130 into the elongate body 4142. The protectivemembers 4107 can be retracted into the elongate body 4142 before, after,or with the suture catch mechanisms 4106. FIG. 69 illustrates the sutureportions 130 positioned through the valve with the suturing device 100being withdrawn from the valve.

With the suture portions 130 positioned through the valve, the sutureportions are tightened to draw together the locations of suturepenetration. As illustrated in FIG. 70, the sutures are then securedtogether by tying or other methods as described above or in the patentsincorporated by reference, which form a part of this specification.

In another embodiment, a suturing device 5100 of a configuration similarto that of FIGS. 62-64 may be used, except that the arm 5104 comprises asingle suture clasp 5126 rather than a plurality of suture clasps 5126.As illustrated in FIG. 71, when a device having an arm 5104A with asingle suture clasp is used, the suturing device is positioned at leastpartially in the mitral valve 8 as illustrated and described inconnection with FIGS. 65-67. FIG. 71 is a schematic partialcross-sectional view of an arm, a needle, and a valve taken along line68-68 in FIG. 67 according to an embodiment employing a suturing devicehaving an arm comprising a single suture mount. As illustrated in FIG.71, the arm 5104A has been positioned on a first side of the valve and asuture catch mechanism 5106A has passed through the tissue of the valvefrom a second side of the valve. The suture catch mechanism 5106A isthen retracted to position the suture portion 130 through the valve asillustrated in FIG. 72.

A second arm 5104B is then positioned to place a second suture portionat a location spaced from the first location as illustrated in FIG. 72.The second arm can be attached to the same elongate body 5142 as thefirst arm 5104A in some embodiments. In other embodiments, the secondarm can be attached to a second device of similar or identicalconfiguration to the prior device. If a second device is employed, itmay be introduced into the mitral valve according to the steps describedabove in connection with FIGS. 65-67 and 71 and a second suture portionis placed through the valve as the suture catch mechanism 106 isretracted through the valve.

FIG. 73 illustrates two separate suture portions positioned through thetissue of the valve 8. Also as illustrated in FIG. 73, first ends of thesuture portions 130 are then secured together by knotting or othermeans, such as described above or in the patents incorporated byreference, which form a part of this specification. The second ends ofthe suture portions 130 are then pulled to draw the suture portionsthrough the tissue and position the secured first ends of the sutureportions adjacent one side of the tissue, as illustrated in FIG. 74. Thesuture portions 130 are tightened to draw together the locations ofsuture penetration through the tissue and secured together, asillustrated in FIG. 75

FIG. 76 is a schematic perspective view of an exemplifying embodiment ofa suturing device comprising a two suture catch mechanisms 6106 and asingle arm 6104 located in proximity to a distal end of an elongate body6142. The suturing device illustrated in FIG. 76 is similar to thesuturing device of FIG. 62, except (1) the suture catch mechanisms 6106of suturing device of FIG. 76 are located distally of the arm 6104 andconfigured to be moved proximally from the retracted position to thedeployed position, (2) the arm 6104 of the embodiment of FIG. 76 extendsdistally and outwardly from the elongate body 6142 such that an anglebetween the arm 6104 and a longitudinal axis of the elongate body 6142is less than 90°, and (3) other changes to the device of FIG. 76compared to the device of FIG. 62 resulting from the first twodifferences as will be understood from the foregoing embodiments.

FIGS. 77-79 schematically illustrate use of the suturing device 6100 ofFIG. 76 according to an embodiment. The valve shown in FIGS. 77-79 canbe a mitral valve 8 and the suturing device can be inserted into thevalve via access through the inferior vena cava and the atrial septum,with or without a guide wire. Although reference is made to the mitralvalve in connection with FIGS. 77-79, the accompanying description canapply to valves other than the mitral valve.

As illustrated in FIG. 77, the distal assembly 6102 of the suturingdevice 6100 is advanced into the passage through the mitral valve 8. Thearm 6104 is extended from the elongate body 6142 and the suturing deviceis advanced through the passage such that the free end of the arm 6104is adjacent a base of the valve as illustrated in FIG. 77. A protectivemember 6107 is then advanced to position the distal end of theprotective member 6107 at or near a base of the valve. A leaflet 132 ofthe valve can be posited between the arm 6104 and the protective memberin some embodiments, such as that illustrated in FIG. 78. Once theprotective member has been advanced, the suture catch mechanism 6106 isadvanced through the tissue of the valve to engage the arm 6104 asillustrated in FIG. 79.

Two suture portions are then passed through the valve tissue essentiallyin the same manner illustrated and described in connection with FIGS.68-70. In embodiments wherein an arm of the suturing device comprisesonly a single suture mount, the suture portions can be placed throughthe valve tissue in essentially the same manner illustrated anddescribed in connection with FIGS. 71-75.

FIG. 80 is a schematic perspective view of an exemplifying embodiment ofa suturing device comprising two suture catch mechanisms 7106 and asingle arm 7104 located in proximity to a distal end of an elongate body7142. The suturing device illustrated in FIG. 80 is similar to thesuturing device of FIG. 76, except the suture catch mechanisms 7106 ofsuturing device of FIG. 80 are located proximally of the arm 7104 andconfigured to be moved distally from the retracted position to thedeployed position and the suturing device of FIG. 80 includes otherchanges compared to the device of FIG. 76 resulting from the arrangementof the arm and suture catch mechanisms as will be understood from theforegoing embodiments.

FIGS. 81-83 schematically illustrate use of the suturing device 7100 ofFIG. 80 according to an embodiment. The valve shown in FIGS. 81-83 canbe a mitral valve 8 and the suturing device can be inserted into thevalve via access through the inferior vena cava and the atrial septum,with or without a guide wire. Although reference is made to the mitralvalve in connection with FIGS. 81-83, the accompanying description canapply to valves other than the mitral valve.

As illustrated in FIG. 81, the distal assembly 7102 of the suturingdevice 7100 is advanced into the passage through the mitral valve 8. Thedistal assembly 7102 is advanced sufficiently far through the passage topermit the arm 7104 to be opened without damaging surrounding tissue.Once the arm 7104 is extended, the suturing device is retracted throughthe passage such that the free end of the arm 7104 is adjacent a base ofthe valve as illustrated in FIG. 82. A protective member 7107 is thenadvanced to position the distal end of the protective member 7107 at ornear a base of the valve. A leaflet 132 of the valve can be positedbetween the arm 7104 and the protective member in some embodiments, suchas that illustrated in FIG. 82. Once the protective member has beenadvanced, the suture catch mechanism 7106 is advanced through the tissueof the valve to engage the arm 7104 as illustrated in FIG. 83.

Two suture portions are then passed through the valve tissue essentiallyin the same manner illustrated and described in connection with FIGS.68-70, except that the positions of the arm and the suture catchmechanisms have been exchanged relative to the valve. In embodimentswherein an arm of the suturing device comprises only a single suturemount, the suture portions can be placed through the valve tissue inessentially the same manner illustrated and described in connection withFIGS. 71-75, except that the positions of the arm and the suture catchmechanisms have been exchanged relative to the valve.

Using the methods illustrated and described in connection with FIGS.65-75, 77-79, and 81-83 sutures can be passed through a variety oflocations near a base of a valve. For example, FIGS. 84 and 85schematically illustrate locations 148 where suture can be placed in avalve. As illustrated in FIG. 84, the suture can be placed through valvetissue at locations 148 generally between adjacent leaflets 132.Alternatively or additionally, sutures may be placed through locations148 at or near a base of a leaflet 132 approximately at the middle ofthe leaflet 132 as illustrated in FIG. 85. The devices and methodsillustrated and described in connection with FIGS. 65-75, 77-79, and81-83 can be used to perform other procedures, such as attachment of aring around the outside of the malfunctioning valve and attachment ofprosthetic devices to tissue. The protective member or needle armdescribed above can also be utilized in the embodiments of the suturingdevice described above for suturing valves, such as edge-to-edgesuturing of mitral valves. In such embodiments, the needle arms may bedeployed to a position that pinches the leaflet between the suture clasparm and the needle arm. The suture catch mechanism or needle may then beadvanced from out of the needle arm, through tissue of the leaflet, andinto engagement with the suture end held by the suture clasp arm.

Although methods have been described for suturing valve tissue using asuturing device having an arm with a single suture mount and using asuturing device with multiple suture mounts in a single arm, otherembodiments can employ a suturing device comprising an arm having morethan two suture clasps and a corresponding number of needles configuredto retrieve suture portions from each of the suture clasps.

FIG. 86 schematically illustrates the chordae tendineae in the leftventricle of a human heart. Positioning the arms of a suturing device ona side of a valve (e.g., the atrial side) opposite the chordae tendineaecan facilitate protection of the chordae tendineae from damage andfacilitate the procedure by avoiding tangling of the arms with thechordae tendineae. Protection members (also described herein as “needlearms”), such as those described herein above and below, can help avoiddamage to the chordae tendineae by suture catch mechanisms, such asneedles for example, located on the same side of the valve as thechordae tendineae (e.g., the ventricular side).

Suturing Devices and Methods Having a Plurality of Arms, Such as forSuturing a Base of A Valve

FIGS. 87 and 88 illustrate an exemplifying embodiment of a suturingdevice 8100 having an elongate body and comprising more than one suturearm 8104 at the distal end of the elongate body, with each arm havingtwo suture clasps 8126. Such embodiments can facilitate performance ofannuloplasty. The illustrated embodiment comprises six arms 8104, witheach arm having two suture mounts 8126, the arms extending perpendicularto a longitudinal axis of the elongate body. Each of the illustratedsuture mounts releasably carries a suture portion for retrieval by asuture catch mechanism. Other embodiments can comprise fewer arms ormore arms than 6. In some embodiments, the device can comprise a singlearm. In some embodiments, the arm(s) can rotate about the elongate body.

The arms illustrated in FIG. 88 are sized to allow the suture mount tobe placed at or near a base of the valve when the body of the device isplaced in an opening of the valve. In some embodiments, the arms aresized and configured such that each of the suture mounts on all of thearms are at or in proximity of the base of the valve when the device isin a valve and the arms have been deployed. For example, the arms caneach have a length of about 1.5 cm and the suture mounts can be locatedat or near an outermost point of the arms. In other embodiments, thearms may be longer or shorter than 1.5 cm. Various embodiments can havearms of different lengths to accommodate the size of the particularvalve to be sutured and the anatomy of the intended patient.

The embodiment of FIGS. 87 and 88 comprises 12 suture catch mechanisms(not illustrated), one for each suture mount of the device. The suturecatch mechanisms can be of the type described above and in the patentsincorporated by reference (which form a part of this specification),such as needles for example. These needles may be located in carriers ina portion of the elongate body proximal to the arms, arrangedcircumferentially around the elongate body to correspond in location tothe suture mounts on the ends of the arms. The suture catch mechanismsmay be actuated by a user to move in a proximal-to-distal direction,extending outwardly away from the elongate body to penetrate throughtissue and into engagement with the suture mounts. Proximal retractionof the suture catch mechanism carries suture away from the arms throughthe tissue and back into the arms. The suture catch mechanisms can beoperated independently of each other, or can be operated in groups insome embodiments. For example, two or more needles can be operatedsimultaneously in some embodiments. Other embodiments are contemplatedwhere there are fewer needles than suture mounts provided on the device,but additional needles can be loaded and reloaded as desired topenetrate through tissue and retrieve suture. In certain embodiments,needles can be housed in a carrier that is rotatable around thecircumference of the elongate body to position the needles in thedesired location relative to the suture mounts.

The suturing device illustrated in FIGS. 87 and 88 comprises aprotection member 8107 that is configured to protect surrounding tissue,e.g. chordae tendineae, from movement of the suture catch mechanisms.The protection member illustrated in FIGS. 87 and 88 is an elongate bodycomprising two lumens 8150 extending through a length of the protectionmember, although the protection member can comprise other numbers oflumens in some embodiments, as discussed above.

The protection member 8107 of this embodiment is configured to movebetween a retracted position parallel to a longitudinal axis of theelongate body and an outwardly extending, deployed position. Theprotection member is also configured to rotate about the longitudinalaxis of the suturing device while the protection member is in theretracted position, the deployed position, and locations between theretracted position and the deployed position in order to point theprotection member toward a desired arm. In some embodiments, theprotection member is configured to rotate about the suturing device onlywhen the protection member is in a selected one or more positions, e.g.fully-retracted position, fully-deployed position, or selected positionbetween full retraction and full deployment.

In some embodiments, the protection member and a cooperating portion ofthe suturing device can be configured with detents to assist a user indetermining when the protection member is aligned with a suture catchmechanism and arm as the protection member rotates. In alternativeembodiments, rather than having a single rotating protection member,multiple protection members may be provided, for example, one per arm,having a number of lumens corresponding to the number of suture mountsin each arm.

The suturing device illustrated in FIGS. 87 and 88 can be used to suturea valve without stopping the beating of the heart. In some embodiments,suturing of the heart while beating can allow the effect of sutureplacement on valve operation to be observed during the procedure,thereby allowing the procedure to be tailored to the needs of theparticular valve by placing only those sutures required to repair thevalve. For example, if the desired repair of the valve has not beenachieved by the placement of initial sutures, continued use of the samedevice or additional devices may be employed through the same accesspath (e.g., through a transapical opening) until the procedure isobserved to be successful on the beating heart. Once the practitionerobserves this success, any access path which has been created to performthe procedure (e.g., the transapical opening) can be closed.

FIGS. 89-94 schematically illustrate a method of suturing using thedevice of FIGS. 87 and 88, and more specifically illustrates a method ofperforming a valve annuloplasty on a beating heart. As illustrated inFIG. 89, a distal end 8102 of the suturing device 8100 is positioned inthe passage through the valve, such as the mitral valve 8, using any ofthe access routes discussed above, and with or without a guide wire. Thedevice is advanced through the valve a sufficient distance to allow thearms 8104 to be deployed without damage to the valve or walls of theheart.

FIGS. 89-94 are illustrated to schematically represent transapicalaccess of the device to the mitral valve 8. However, as discussedherein, other access routes can be used and other valve can be sutured.In FIG. 89, the valve is shown in cross section along a plane passingthrough a longitudinal axis of the suturing device 8100. In FIGS. 90-92,the valve is shown in cross section on two planes, which both intersectthe longitudinal axis of the suturing device 8100. A first plane extendsalong the arm 8104 which is illustrated at approximately a 9 o'clockposition from the elongate body of the suturing device. The second planeextends along the arm 8104 which is illustrated at approximately a 5o'clock position relative to the elongate body of the suturing device.Thus, five of the arms 8104 are illustrated in FIGS. 90-92 as generallyoverlying leaflets 132 of the valve, with a portion of one of theleaflets which underlies the sixth arm being hidden from view. In FIG.91, the planes of cross section of the valve pass generally through thelongitudinal axis of the suturing device and extend generally along thearms 8104 which are illustrated at the 5 o'clock and 7 o'clock positionssuch that all six of the illustrated arms are shown generally overlyingthe leaflets 132 of the valve 8. The chordae tendineae are omitted fromview in FIGS. 89-94.

Once the arms have been extended, the device 8100 can be retractedthrough the valve 8 to place the ends of the arms at or near the base ofthe valve 8, as illustrated in FIG. 90. In certain embodiments, thelength of the arms will not correspond exactly with the size of thevalve. In such embodiments, two of the arms may be placed in a desiredlocation with respect to the base of the valve where sutures are desiredto be placed. The protective member 8107 is then moved from theretracted position toward the deployed position as illustrated in FIG.91.

As shown in FIG. 91, the protective member 8107 when deployed can bemoved to positions located angularly between the suture arms 8104. Inother embodiments, the protective member 8107 when deployed can bepositioned at a rotational orientation relative to the body of thesuturing device 8100 that is aligned with at least one of the suturemounts of a suture arm. The ability to move the protective memberbetween the arms can be advantageous in some embodiments. For example,movement of the protective member between the arms can allow theprotective member to be rotated about the device between a positionedaligned with a first arm 8104A, as illustrated in FIG. 92, and aposition aligned with a second arm 8104B, as illustrated in FIG. 93,without damage to the chordae tendineae. This feature can also helpavoid tangling of the protection member 8107 with the chordae tendineaeas a reduced number of instances of deployment and retraction occur.

In one embodiment, the protective member 8107 is first deployed andpositioned in alignment with a suture mount 8126 of the first arm 8104A,as shown in FIG. 92. The end of the protective member 8107 may belocated near the end of the arm 8104A, but on the opposite side oftissue of valve 132. In some embodiments, the end of the protectivemember 8107 is positioned a few millimeters away from the arm 8104A. Inother embodiments, this distance may be adjustable. A first suture catchmechanism, such as a needle, can be deployed through one of the lumensof the protective member 8107, through tissue of valve 132, and into thesuture mount 8126A of the first arm 8104A. Retraction of the suturecatch mechanism carries a first suture end portion through the tissue ofvalve 132 and into the elongate body.

With the suture catch mechanism retracted and the protective member 8107deployed, the protective member can be rotated into alignment with asuture mount of the second arm 8104B, as shown in FIG. 93, for example.A second suture catch mechanism, such as a needle, can be deployedthrough the other of the lumens of the protective member 8107, throughtissue of valve 132, and into the suture mount 8126B of the second arm.This suture mount of the second arm preferably holds the second end ofthe suture mounted in the first arm. Retraction of the suture catchmechanism carries the second suture end portion through the tissue ofvalve 132 and into the elongate body. The suturing device at this pointhas desirably placed a suture along the circumference of the valve at anangular distance corresponding to the angular distance between the endsof the two adjacent suture arms.

At this point in the procedure only one of the suture mounts from thefirst arm and the second arm has been used, preferably the suture mountsclosest to the corresponding adjacent arm. The protection member 8107may then be retracted and rotated to a location between another pair ofarms, such as the second arm and the third arm. The device 8100 may alsobe desirably repositioned such that the second and third arms may bepositioned as needed at the base of the valve 132. The steps discussedin connection with FIGS. 90-93 are then repeated to place a secondsuture through two additional locations in the valve. In embodimentswherein these steps are repeated for each of the pairs of adjacentsuture arms, six sutures 130 may be positioned through the valve asillustrated schematically in FIG. 94. Opposing ends of each suture canthen be tightened and secured together by any known method, such asthose described herein.

In some embodiments, methods similar to those described in connectionwith FIGS. 89-94 can be used to attached a prosthetic device to cardiactissue.

Suturing Devices and Methods Having Two Arms, Such as for Suturing aBase of A Valve

FIGS. 95-97 illustrate an embodiment of a suturing device 9100 that canbe used to suture an anatomical valve, such as a heart valve. Forexample, the suturing device 9100 (as well as similar devices describedabove) can be used to perform an annuloplasty by plication, wheresuture(s) are applied to a section of a valve and the suture(s) istightened to reduce the size of the valve to remodel the valve. Thesuturing device 9100 illustrated in FIGS. 95-97 is similar in somerespects to suturing devices illustrated and described above. Forexample, the suturing device can comprise an elongate body 9142 and adistal assembly 9102 that can have one or more suture arms 9104, as inthe suturing device of FIGS. 87 and 88 described above. As illustrated,the suturing device has only a single suture mount 9126 on each suturearm 9104, although in some embodiments it can have multiple suturemounts 9126 on each arm 9104. As described above, the suture mounts 9126can be configured to releasably hold a suture portion.

In some embodiments, the suturing device can have multiple suture arms9104 and multiple protective members or needle arms 9107. In theillustrated embodiments, the device has two suture arms 9104A,B and asingle needle arm 9107. The configuration and deployment of the arms, aswell as other features and ways of operating the suturing device, may beas shown and described in the U.S. Pat. No. 6,911,034, the entirety ofwhich is hereby incorporated by reference. The suture arms can bepositioned near a distal end of the device, and the needle arm can bepositioned proximally to the suture arms, as illustrated in FIGS. 95-97.The suture arms and the needle arm can each have a retracted position inwhich they are retracted within the elongate body, as illustrated inFIG. 96. Each suture arm can also have an extended position in which thesuture arm rotates about one end and extends away from the elongatebody. In some embodiments, the arms 9104A,B can extend perpendicular toa longitudinal axis of the elongate body when in the extended position.The needle arm can also be deployed to an extended position, in whichthe needle arm extends away from the elongate body and toward a distalend of the elongate body. FIG. 97 illustrates an embodiment where bothsuture arms and the needle arm are in the extended position.

As described above, various embodiments can have arms 9104A,B ofdifferent lengths to accommodate the size of the particular valve to besutured and the anatomy of the intended patient. In some embodiments,the arms are sized and configured such that each of the suture mounts onthe arms are at or in proximity of the base of a valve when the deviceis in the valve and the arms have been deployed. In some embodiments,when the arms have been deployed and the suture mounts are at or inproximity of the base of a valve, the needle arm can be on an oppositeside of the valve. In some embodiments, the needle arm in its extendedposition can extend into alignment with a suture mount of a suture arm,but with the valve between them. Additionally, in some embodiments asuture arm can comprise a sharp edge 10105, or any hook, point, needletip, knurling, or other roughening at a distal end on a surface thatfaces toward a proximal end of the elongate body when the suture arm isextended, as illustrated in FIG. 98. The sharp edge or other rougheningcan help retain the suture arm in a position against tissue of ananatomic valve.

Also as described above, the needle arm 9107 can be configured toprotect surrounding tissue from movement of a suture catch mechanism,which in some embodiments can be a needle 9106. The needle arm cancomprise one or more lumens 9150 through which one or more needles 9106can pass. In the illustrated embodiment of FIG. 97, the needle arm hastwo lumens, each of which can be associated with a needle 9106 and asuture mount 9126.

In some embodiments, the needle arm can rotate around the elongate body.As illustrated in FIG. 97, the needle arm can extend between the twosuture arms 9104A,B. In FIG. 99, the needle arm has rotated intoalignment with one of the suture arms 9104A and a suture mount 9126A.FIG. 99 illustrates a cross sectional view of a section of the elongatebody with the suture arm 9104A and the protection member 9107 in theirextended positions, and the needle arm aligned with the suture arm9104A. As illustrated, a needle 9106 is positioned within the needle arm9107. In some embodiments, the needle 9106 can be positioned within theneedle arm before the needle arm is deployed to its extended position.

In some embodiments, the elongate body can comprise a rotating sleeve9160, which can surround an inner cylinder, and which can house theneedle 9106 and the needle arm 9107 when the needle arm is in theretracted position. As illustrated, when the needle arm is in itsextended position the needle runs through the rotating sleeve, exits therotating sleeve into a gap, and then enters the needle arm. In someembodiments, the needle can run directly into the needle arm withoutpassing first to a gap between the rotating sleeve and the needle arm.In some embodiments, discussed in more detail below, at least part ofthe needle can be within an extrusion. In some embodiments, theextrusion can be located only within the needle arm. In someembodiments, the extrusion can extend from the needle arm when theneedle arm is in its extended position into the rotating sleeve.

When the needle arm begins to move into the extended position from aretracted position within the rotating sleeve it first moves distallyuntil it engages extension surface 9164. The extension surface anglesthe needle arm away from the elongate body, such that as the needle armcontinues to move forward it moves both away from the elongate body andtoward a distal end of the elongate body. In some embodiments, theextension surface 9164 can be at approximately a 45 degree angle. Insome embodiments, the needle arm can extend at approximately a 45 degreeangle. In other embodiments, the extension surface can be at an angleless than or greater than 45 degrees, and the needle arm can be at anangle less than or greater than 45 degrees. As the needle arm isretracted, it can engage against retraction surface 9166 which can guidethe needle arm back into its retracted position within the rotatingsleeve 9160. In some embodiments, the retraction surface can comprise agap that can allow a needle and/or extrusion to pass through it.

In some embodiments, the rotating sleeve 9160 can be configured torotate about a longitudinal axis of the elongate body. In someembodiments, in addition to being able to rotate, the rotating sleevecan move proximally or distally along the inner cylinder. As therotating sleeve rotates, the needle arm can rotate with it. As describedwith respect to FIGS. 87 and 88, the sleeve and needle arm, in variousembodiments, can be configured to rotate while the needle arm is in theretracted positioned, the extended position, and/or in locations betweenthe retracted position and the extended position in order to point theneedle arm toward a desired arm. In some embodiments, when the needlearm is pointed toward a desired arm a gap of greater than or equal to 3millimeters (or about 3 millimeters) and/or less than or equal to 5millimeters (or about 5 millimeters) can exist between the needle armand the suture arm. In some embodiments, the needle arm can pointbetween two arms and a gap of greater than or equal to 3 millimeters (orabout 3 millimeters) and/or less than or equal to 5 millimeters (orabout 5 millimeters) can exist between the needle arm and a plane onwhich the two arms lie.

In some embodiments, the elongate body can have one or more detents9162, which can be positioned such that as the rotating sleeve rotatesit can engage a detent when the needle arm is in alignment with a suturearm 9104. In some embodiments, the detent or detents can be configuredsuch that as the rotating sleeve engages with the detent the sleevemoves distally. In some embodiments, this can be achieved by creating abayonet connection between the sleeve and the detent(s). The distalmotion of the rotating sleeve can drive the needle arm distally, and canbe configured such that the needle arm engages tissue of the valve,pinching the valve between the tissue and the suture arm. If the needlearm rotates back, the rotating sleeve can disengage the detent, movingproximally and releasing the valve. In some embodiments, the needle armcan move distally as it comes into alignment with a suture arm, but doesnot pinch the valve. In some embodiments, the needle arm can movedistally as it comes into alignment with a suture arm, but can rotateback without moving proximally.

Pinching the valve can help facilitate suturing a valve without stoppingthe beating of the heart, because it can help ensure desired placementof sutures. As discussed above, suturing of the heart while beating canallow the effect of suture placement on valve operation to be observedduring the procedure, thereby allowing the procedure to be tailored tothe needs of the particular valve by placing only those sutures requiredto repair the valve. For example, if the desired repair of the valve hasnot been achieved by the placement of initial sutures, continued use ofthe same device or additional devices may be employed through the sameaccess path (e.g., through a transapical opening) until the procedure isobserved to be successful on the beating heart. Once the practitionerobserves this success, any access path which has been created to performthe procedure (e.g., the transapical opening) can be closed.

FIG. 100 illustrates a view of the suturing device from a distal end. Asillustrated, the first and second suture arms 9104A,B have been extendedand extend away from the elongate body at approximately 90 degrees fromeach other. In some embodiments, the suture arms can be positioned atless than 90 degrees from each other, and in other embodiments thesuture arms can be positioned at more than 90 degrees from each other.The distance 9127 between the suture mounts 9126A,B can define theinitial width of a suture or other element that can be tightened whenperforming an annuloplasty. In some embodiments, the distance 9127 canbe greater than or equal to 10 millimeters (or about 10 millimeters)and/or less than or equal to 15 millimeters (or about 15 millimeters).Also illustrated in FIG. 100 is a guide wire 10 and a guide wire lumen9111 through which the guide wire can pass. As discussed above, in someembodiments the device can advance over a guide wire to reach a locationwithin the heart.

FIG. 101 illustrates a cross sectional view of a distal end of a needlearm 9107. In some embodiments, the needle arm can have one or morechannels through which needles can pass. In some embodiments, asillustrated, a needle arm can have one or more extrusions 9170positioned within one or more channels of the needle arm. The extrusioncan be configured to receive a needle 9106, as illustrated. In someembodiments, the needle arm can have one or more of a draft 9174, atunnel 9172, and/or a suture retaining area 9176, with the extrusionextending only as far as the draft 9174. The draft 9174 can guide aneedle into the tunnel 9172, which can help ensure that the needle isaligned to pass through a suture clasp or mount 9126 and receive asection of a suture. The suture retaining area 9176 can be of a sizesufficient to house both a needle and a portion of suture caught by theneedle. In some embodiments, the needle 9106 can be pre-loaded to theillustrated position, extending through the extrusion and through thetunnel 9172, before a needle arm is deployed to an extended position. Insome embodiments, the needle can be pre-loaded into other positionswithin the needle arm and/or extrusion, such as within the extrusion butshort of the tunnel. The needle 9106 as illustrated in FIG. 101 (or inany of the embodiments described elsewhere herein) may have a hook atits distal end to engage a portion of suture held by arm 9104A or 9104B.Sutures as described herein (or elsewhere in the specification) may haveends that are flattened with a hole formed therein for engaging theneedle, as described in the U.S. Pat. No. 7,090,686, the entirety ofwhich is hereby incorporated by reference.

In some embodiments, the needle arm can have a single extrusion 9170with one or more lumens 9150. FIG. 102 illustrates a top view of anextrusion 9170 with two lumens 9150 configured to hold two needles 9106.In some embodiments, the needle arm can have multiple extrusions, eachextrusion associated with one or more needles. In some embodiments, theneedle arm can have a draft, tunnel, and/or a suture retaining area asdescribed above for each lumen and/or needle. In FIG. 102, the extrusionhas parallel sides and rounded corners. In other embodiments, theextrusion or extrusions can be square, rounded, ovular, or of any shapethat can fit within a needle arm. The various embodiments andconfigurations of an extrusion or extrusions can be used with anyprotective member (“needle arm”) discussed in the present application.

FIGS. 103-112 illustrate schematically one method of using a suturingdevice to perform an annuloplasty. The illustrated procedure representstransapical access of the device to the mitral valve 8, although asdiscussed herein other access routes can be used, including routes bywhich the device enters the valve from the atrial side, and other valvescan be sutured. The device can also access the valve with or without aguide wire. The valve is shown without surrounding tissue, and in FIG.103 a distal end of the device has been inserted through the valve, withthe suture arms 9104A,B and needle arm 9107 in the retracted position.The needle arm is positioned approximately equidistant between the twoarms, although in some embodiments the needle arm can be positionedcloser to one arm or the other. Also illustrated schematically arechordae tendineae 133 extending from the ventricle side of the valve.

The suture arms can be placed in their extended positions, asillustrated in FIG. 104. In some embodiments they can reach theirextended position simultaneously, and in some embodiments one arm canbegin to extend or reach the extended position before the other armbegins to extend. With the suture arms extended, the device can beretracted until the arms engage tissue of the valve, as illustrated inFIG. 105. As illustrated, the suture mounts 9126A,B are along a base ofthe valve on the same leaflet. In some embodiments, the arms do notextend all the way to the base of the valve, and in some embodimentseach arm can be over a different leaflet.

Either before, after, or while the suture arms are extending or thedevice is retracted such that the suture arms can engage tissue of thevalve, the needle arm can be deployed to an initial extended position,such as past the chordae, for example. FIG. 106 illustrates the needlearm in the extended position and the suture arms in place on the valve.The needle arm 9107 can then rotate toward a first arm 9104A until it isaligned with the arm, as illustrated in FIG. 107. As discussed above, insome embodiments, when the needle arm is aligned with the arm it canextend distally and pinch the valve between the suture arm and theneedle arm. In other embodiments, there can be a gap between the needlearm and the valve.

As the needle arm rotates, it can displace chordae tendineae 133positioned between the needle arm and the first arm. One advantage ofhaving the needle arm positioned initially equidistant between the twoarms 9104A,B is that it minimizes the distance that the needle arm mayneed to travel to reach each arm, which can minimize stress on anydisplaced chordae. The needle arm when extended is preferably positionedbetween adjacent chordae tendineae, such that movement of the needle armbetween the first and second arms does not cause the needle arm totangle with the chordae tendineae.

Once the needle arm is aligned with the suture arm, a needle 9106A canbe extended out of the needle arm and through the suture mount 9126A, asillustrated in FIG. 108. As discussed above, retraction of the needlecan carry a first suture end portion from the suture mount, throughtissue of the valve, and into the elongate body. The needle arm can thenrotate back to its initial extended position, bringing a length ofsuture 130A with it, as illustrated in FIG. 109.

From the initial extended position, the needle arm 9107 can rotatetoward second arm 9104B until it is aligned with the arm, as illustratedin FIG. 110. In some embodiments, the needle arm can pinch the valvetissue against the arm, as discussed above. Also as discussed above, andas illustrated, the needle arm can displace chordae tendineae 133positioned between the needle arm and the second arm 9104B.

A separate needle 9106B can extend through the needle arm and throughthe suture mount, as illustrated in FIG. 111, and then retract into theelongate body with a second suture end portion. The needle arm can thenreturn to its initial extended position, as illustrated in FIG. 112,with a length of suture extending from each arm through the valve andinto the needle arm. In some embodiments, the elongate body can have aninitial detent that informs a user when the needle arm has returned toits initial extended position.

The suture arms and the needle arm can retract into the elongate body.In some embodiments, the needle arm and/or the suture arms can retractinto the elongate body before the needle arm returns to the initialextended position, or without the needle arm returning to the initialextended position. Once the needle arm and suture arms are retracted,the device can be removed from the valve and the heart, leaving thesuture lengths running through the valve.

In some embodiments, the two suture end portions can be parts ofseparate sutures, as illustrated in FIG. 113. The two suture ends thatpass through the gap in the valve can be secured together by tying aknot 134 according to any known method or by applying a knot 134, suchas described in U.S. Patent Publication No. 2007/0010829 A1, publishedJan. 11, 2007, which is hereby incorporated by reference herein in itsentirety and is considered a part of this specification. FIG. 114illustrates the sutures after they have been joined together. In someembodiments, the two suture end portions can be ends of the same suture,and it is not necessary to secure the two suture ends together as seenin FIG. 113.

One or more of the loose suture ends can then be pulled, as describedwith reference to FIGS. 50 and 51, bringing the suture against thevalve. The remaining ends can be tightened and tied according to any ofthe methods described above, such as FIGS. 69 and 70 and accompanyingdescription, to thereby draw together the locations of suturepenetration. In some embodiments, as described above, the initialdistance between the set of suture penetrations can be greater than orequal to 10 millimeters (or about 10 millimeters) and/or less than orequal to 15 millimeters (or about 15 millimeters). In some embodiments,the distance between the set of suture penetrations can be tightened toa second distance greater than or equal to 6 millimeters (or about 6millimeters) and/or less than or equal to 8 millimeters (or about 8millimeters). The connection between the set of suture penetrations canbe referred to as a plication, and in some embodiments multipleplications can be inserted into the valve with the suturing device. Theplications can be positioned and sized to reshape the valve according toa desired treatment goal.

In some embodiments, a tube 9137 can be inserted over the suture, asillustrated in FIG. 115, which is a cross sectional view of a valve witha plication. The tube can be made of metal or a plastic, such aspolypropylene, and can be straight or curved. In embodiments where thetwo suture end portions are part of separate sutures, the tube can beinserted over one of the suture ends that pass through the gap in thevalve before the suture ends are secured together. In some embodiments,the tube 9137 can be secured to the two free ends of separate suturesthat pass through the gap in the valve, rather than sliding loosely overthe joined sutures. The loose ends can then be pulled until the tubesits against or is near the valve. In embodiments where the two sutureend portions are part of the same suture, the tube can be inserted overand/or attached to the suture before the suture is attached to thedevice, or in some embodiments the tube can be attached to the sutureafter the suture is attached to the device. The tube can be set to adesired length and can help control the distance that the locations ofsuture penetration are drawn together, as illustrated in FIG. 116. Insome embodiments, a pledget can be used instead of a tube. With the tubeor pledget in place, a knot can be applied on the opposite side of thevalve, as illustrated in FIG. 116.

In some embodiments, in order to maintain consistent tightening amongmultiple plications, or to monitor the tightening of a single plication,a strain gauge can be connected to the suture. In some embodiments, astrain gauge can be built into the handle of the device. The plicationcan be tightened until the strain gauge indicates a desired value. Insome embodiments, a first plication can be tightened to a desireddistance, and the value measured by a strain gauge recorded. Subsequentplications can then be tightened to approximately the same reading ofthe strain gauge.

Because the chordae were pushed aside as the needle arm rotated betweenthe two suture arms, the suture on the ventricle side can run in agenerally direct route between the suture penetrations. This can helpprevent unnecessary strain on chordae that could result if the suturetook a circuitous path around chordae as it ran from one suturepenetration to the next. Tightening the suture could pull the suturetight against the base of one or more chordae, potentially damaging thechordae.

Example Device for Applying Knots

Varying embodiments described herein rely on joining one or more suturestogether. The following description relates to devices and methods ofjoining sutures. FIG. 117 illustrates one embodiment of a knot placementdevice 900 that can be used to apply a knot to the suture portion 130.The knot placement device 900 can include a handle 902 and a shaft 904extending distally from the handle. The handle 902 can include anelongate tubular body extending from a proximal end to a distal end, andcan include an actuator 906 and a distal end portion 910. The handle 902can further comprise a cam 908 and a spring 912, shown in its restposition, disposed between the cam 908 and end portion 910. The actuator906 can be a thumb or finger button in contact with the cam 908. Endportion 910 can be fixedly attached to an outer tube 914 by glue, pressfit, injection molding, or other suitable means known to one of ordinaryskill in the art. An intermediate tube 916 can be concentrically andslidably disposed within the outer tube 914. A push rod 918 can beconcentrically and slidably disposed within the intermediate tube 916and fixedly attached to the cam 908. It should be appreciated that it iscontemplated that the knot placement device 900 does not necessarilycomprise an intermediate tube 916; however its inclusion providescertain benefits.

Depression of the actuator 906 causes the cam 908 to move distally,compressing the spring 912, thereby moving the push rod 918. Aftertraveling for a certain desired distance, the cam 908 engages a proximalend of the intermediate tube 916, causing the intermediate tube 916 toalso move distally. Upon release of the actuator 906, the spring 912expands to move the cam 908 and the push rod 918 proximally. In theillustrated embodiment, the intermediate tube 916 can be freely slidableover the push rod 918.

In one embodiment, not shown, the cam 908 can include a detent in thesurface which contacts the actuator 906. The detent can signal to theuser a specific degree of advancement of the push rod 918, theintermediate tube 916, or both. For example, the detent can signal thatthe push rod has been advanced sufficiently far to insert the plug intothe knot body, as described below. The detent can also indicate travelup until, but not including, the point at which the cam 908 engages theintermediate tube 916. The detent can be shaped so as to prevent theactuator 906 from returning to its original position. The cam cancomprise multiple detents to indicate multiple increments of travel. Toreturn the actuator to its initial position, the actuator and cam caninclude a mechanism such that after the actuator can be fully depressed,the actuator can automatically return to its initial position.Alternatively, the actuator can have a locked configuration, either atone of the detents or in a fully depressed configuration, and the handlecan include a mechanism by which a second actuator can be used torelease the cam and actuator to return to their initial positions.

In one embodiment, not shown, the intermediate tube 916 can comprise akeyway and the outer tube 914, the end portion 910, or both can comprisea key. Alternatively, the intermediate tube 916 can comprise a key andthe outer tube 914, the end portion 910, or both can comprise a keyway.Providing such a key and keyway can be used to keep the intermediatetube 916 aligned with the outer tube. Other embodiments are contemplatedto maintain rotational alignment of the intermediate tube, such asrotationally fixing the intermediate tube relative to the push rod.Providing such a key and keyway can also be used to constrain the rangeof sliding movement of the intermediate tube 916.

As shown in FIG. 118, a knot, comprising a knot body 924 and a plug 926,can be disposed within the outer tube 914 at its distal end. In anotherembodiment, the knot body can include an atraumatic tip 932. The tip 932can be rounded and have an outer diameter about the same as that of theouter tube 914. The tip can also include a flat transition 934 as well.The tip 932 can be integrally formed with the knot body 924 or can beseparately attached. As illustrated, the tip 932 can have an aperture936 extending axially through the tip, opening to the cavity inside theknot body. When the knot is delivered into a patient as described above,the atraumatic tip prevents damage to the patient.

Alternatively, the fit between the knot body 924 and the outer tube 914cannot retain the knot body 924 in the outer tube 914. The knot body 924can be at the distal end of the outer tube 914, and can protrudeslightly distal to the distal end of outer tube 914. The plug 926 can bepositioned proximal to the knot body 924, and can be slidably disposedwithin the intermediate tube 916, having a distal end located proximallyfrom the knot body and distally from the push rod 918. The plug 926 hasan outer dimension configured to be inserted into an inner cavity of theknot body 924. The intermediate tube 916 can be sized and positionedsuch that its distal end can abut knot body 924.

As shown in FIG. 118, the outer tube 914 can include a side hole 920near its distal end. The intermediate tube 916 can include a slot (notshown) extending proximally from its distal end, forming a C-shapedcross section. At a proximal end of the slot, a sharpened cuttingsurface can be provided to cut suture 130, as described below. The slotcan also be spaced from the distal end of the intermediate tube, suchthat the distal end of the tube still forms a complete circle incross-section. The outer tube 914, intermediate tube 916 and push rod918 can be made of any suitable material, including but not limited tometals, plastics, and a combination of metals and plastics.

As shown in FIG. 118, in a preloaded configuration, the knot placementdevice 900 can include a threader 928 comprising a tab 931 and a loopedwire 930 passing through the side hole 920 in the outer tube 914. Thewire 930 extends through the slot 122 located in the intermediate tube916, and through knot body 924, exiting through opening 936 at thedistal end of the knot body 924. The threader 928 can be used to loadthe suture into the knot placement device as described below. Thethreader 928 also prevents the knot body 924 from escaping from theplacement device 900 when the knot body can be provided with an outerdimension of the same or smaller size than the inner wall of the outertube 914.

With reference to FIG. 118, the knot body 924 can be generally tubularand comprise a proximal end, a distal end, and a longitudinal axis. Theknot body 924 further defines an inner cavity and can include an opening936 at its distal end. The knot body can be of a generally constantinner diameter and outer diameter. Alternatively, the inner diameter,the outer diameter, or both can generally taper along the longitudinalaxis of the knot body. Alternatively, the inner diameter, the outerdiameter, or both can generally taper along a portion of thelongitudinal axis and can be of a generally constant inner diameter,outer diameter or both over a portion of the longitudinal axis.

The opening 936 at the distal end of the knot body can, in someembodiments, be of a reduced diameter relative to an inner cavity of theknot body 924. The knot body also can include an opening at the proximalend. The opening at the proximal end can, in some embodiments, be of areduced diameter relative to an inner cavity of the knot body 924. Theknot body can further comprise protrusions 938 extending from the innersurface of the knot body 924 toward the longitudinal axis. Protrusions938 can be formed as rings as illustrated, or as spirals, spikes, bumps,or other suitable structures or combinations of structures.

Referring to FIG. 118, in one embodiment, the knot body 924 can belocated distally from the plug 926 within the outer tube 914. The plugcan be sized to be inserted into the inner cavity of the knot body 924,and can have a tapered configuration. Alternatively, the plug 926 canhave a constant cross-section over a majority of its length, with atapered, chamfered or rounded distal end for facilitating insertion intothe knot body 924. The outer dimension of the plug 926 can be slightlylarger than the inner dimension of the cavity of the knot body 924, suchthat when the plug is inserted into the cavity, a relatively secure fitcan be provided between the two. The protrusions 938 within the knotbody further facilitate the relative securement. The plug 926 can alsocomprise indentations, not shown, for receiving the protrusions 938 tosecure the plug 926 more surely in the knot body 924. Other embodimentsare contemplated wherein protrusions can be formed on the plug 926 withor without indentations formed in the inner cavity of the knot body 924.It is also contemplated that in some embodiments both the plug 926 andthe knot body 924 can comprise protrusions and indentations,respectively. In certain embodiments, insertion of the plug 926 into theknot body 924 can cause the knot body 924 to slightly expand. Both theknot and the knot body can be formed of any suitable resilientmaterials, and in one embodiment, can be made from the same material asthe suture, more preferably polypropylene.

FIGS. 118-119 illustrate one embodiment for placing a knot utilizing theknot placement device 900 described above. A pair of sutures ends 130can be passed through the loop 930 of threader 928. The threader can bepreloaded into the knot placement device 900 as described above. The tab931 of threader 928 can be pulled proximally to dispose suture 130 inthe device. Suture 130 can be held in tension, by hand or otherwise,while the device 900 can be advanced until the knot body 924 or shaft904 contacts at least one tissue portion. The actuator 906 can bedepressed to advance the push rod 918, thereby forcing the plug 926distally into the knot body 924 and trapping suture 130 there betweenthe plug 926 and the knot body 924. The actuator can be furtherdepressed until the cam 908 contacts the proximal end of intermediatetube 916, causing the intermediate tube 916 to contact knot body 924 andeject the knot from the shaft 904. Advancement of intermediate tube 916can also cause cutting surface to sever suture 130 where it extends outof opening. The knot placement device can then be removed, leaving theknot in place against the tissue portions.

In one embodiment, the knot can be ejected from the shaft 904 whileleaving the sutures 130 un-severed. For example, the knot can be ejectedbefore the cutting surface reaches the suture 130. In anotherembodiment, no intermediate tube can be provided, and the suture can becut manually.

In an embodiment including the intermediate tube, the device 900 can beconfigured such that the distal ends of the outer tube 914, intermediatetube 916, and the push rod 918 lie generally flush relative to oneanother and can be held relatively in position. This position can beheld, for example, by depressing the actuator until it rests in a detentin cam 908. The detent can signal to the user that the plug 926 has beeninserted into knot body 924, but also that the sutures 130 have not beencut. At such time, the placement device can be used to further advancethe knot against tissue portions using the distal end surface of theshaft. The actuator can be further depressed to advance the push rod 918and intermediate tube 916 to sever sutures 130.

The actuator 906 and cam 908 can also be provided with lockingmechanisms that prevent the actuator 906 from returning to its originalposition. Further details are provided in U.S. Patent ApplicationPublication No. 2006/0069397, published on Mar. 30, 2006, the entiretyof which is hereby incorporated by reference herein. Such an embodimentcan be advantageous to hold the push rod flush with the distal end ofthe outer tube to provide a surface that can be utilized to furtheradvance and position the knot against tissue portions.

It will be appreciated that other embodiments can be contemplatedwithout use of the intermediate tube, but can still be capable ofsevering the suture. For example, the push rod can be provided withportions of differing diameter. A distal, smaller diameter can be sizedto engage the plug 926 to push the plug into the knot body 924. Aproximal, larger diameter can be provided on the push rod, which caninclude a sharpened surface at the transition between the larger andsmaller diameter sections. Once the smaller portion of the push rodpushes the plug 926 into the knot body 924, the larger portion of thepush rod can engage the knot body 924 to push the knot out of theplacement device, while the sharpened surface on the push rod can severthe suture.

In the embodiment described above, when the knot body 924 and the plug926 as described above are secured together, suture portions extendingthrough the inner cavity of the knot body will be fixedly securedtherein, forming a knot. It will be appreciated that many otherembodiments can be possible for forming a knot, including various othershapes and configurations for the knot body and plug, as well asembodiments wherein only one component can be used to provide securementrelative to a suture. It will also be appreciated that in thoseembodiments in which the knot can include a knot body and plug, the plugcan be located within the shaft proximally from the knot body or theknot body can be located within the shaft proximally from the plug.

After the procedure within the heart is complete, any path that has beenopened to provide access for entry of the suturing device to the body(e.g., the transapical opening) can be closed. Additional detailsregarding closure of transapical openings are provided in U.S. PatentPublication No. 2011/0190793 A1, entitled METHODS AND APPARATUSES FORSUTURING OF CARDIAC OPENINGS, which is hereby incorporated by referenceherein in its entirety and forms a part of this specification.

Although the foregoing description of the preferred embodiments hasshown, described and pointed out the fundamental novel features of theinvention, it will be understood that various omissions, substitutions,and changes in the form of the detail of the apparatus as illustrated aswell as the uses thereof, may be made by those skilled in the art,without departing from the spirit of the invention. For example, whilethe suturing device is described with respect to suturing a valve of apatient's heart, it is further envisioned that the suturing device couldbe used to close or reduce a variety of other tissue openings, lumens,hollow organs or natural or surgically created passageways in the body.The suturing device can have any suitable number of arms, such as two orfour or more, and any given arm can have one or more suture clasps oropenings.

What is claimed is:
 1. A suturing device, comprising: an elongate membercomprising a distal end; at least two arms connected with the elongatemember near the distal end for movement between a retracted position andan extended position, each of the at least two arms comprising at leastone suture mount located near a free end of each of the at least twoarms and configured to releasably retain a suture portion; at least twoneedles each configured to move between a retracted position and adeployed position to retrieve the suture potion retained in the at leastone suture mount when each of the at least two needles is moved from theretracted position to the deployed position and returned to theretracted position; and a protective member configured to inhibitcontact between a distal end of each of the at least two needles andsurrounding tissue during at least a portion of the movement of each ofthe at least two needles from its retracted position toward its deployedposition; wherein the protective member is moveable into alignment witheach of the at least two arms; and wherein each of the at least two armsin its extended position has a free end, the free ends being spacedapart from each other, and the protective member is configured to housethe at least two needles and move between locations adjacent each of thefree ends of the arms.
 2. The suturing device of claim 1, wherein theprotective member is configured to move between a retracted position andan extended position.
 3. The suturing device of claim 2, wherein theprotective member is configured to move from its retracted position toits extended position before the needles are deployed.
 4. The suturingdevice of claim 2, wherein the protective member is configured to movefrom its retracted position to its extended position while the at leasttwo needles are being moved from their retracted positions to theirdeployed positions.
 5. The suturing device of claim 2, wherein theprotective member comprises a sleeve and the at least two needles areconfigured to extend through the sleeve when the at least two needlesare in their deployed positions.
 6. The suturing device of claim 2,wherein the protective member is configured to partially surround acircumference of each needle when the at least two needles are in theirdeployed positions.
 7. The suturing device of claim 1, wherein each armcomprises a first suture mount and a second suture mount located near afree end of each arm and configured to releasably retain a second sutureportion, one of the at least two needles being configured to movebetween a retracted position and a deployed position to retrieve thesecond suture potion retained in the second suture mount when the one ofthe at least two needles is moved from the retracted position to thedeployed position and returned to the retracted position.
 8. Thesuturing device of claim 1, wherein the protective member is configuredto partially surround the at least two needles when the at least twoneedles are in their deployed positions.
 9. The suturing device of claim8, wherein the protective member has a generally U-shaped cross-section.10. The suturing device of claim 1, wherein the suturing devicecomprises six arms and twelve needles.
 11. The suturing device of claim1, wherein the protective member comprises a pair of lumens.